Recalibrating the COMPASS: Insights from the first global deployment of CEREGLIDE™ 71 Intermediate Catheter in endovascular treatment of stroke

Abstract

Purpose

Endovascular treatment has become the standard of care for the treatment of patients with acute ischemic stroke with large vessel occlusion, however, the optimal first-line strategy for mechanical thrombectomy continues to be debated. Recent advancements in large-bore aspiration catheters have enhanced the efficacy of A Direct Aspiration First Pass Technique (ADAPT), offering promising improvements in procedural success. This study aims to evaluate the characteristics and technical outcomes associated with endovascular treatment for acute ischemic stroke following the inaugural global use of the CEREGLIDE™ 71 Intermediate Catheter at our institution.

Materials and methods

In this retrospective, single-center study, a total of 25 consecutive patients with verified large vessel occlusion in the anterior circulation were included from October 2023 to May 2024. All patients were treated with endovascular therapy using a CEREGLIDE™ 71 intermediate catheter. The angiographic outcome was assessed using the thrombolysis in cerebral infarction (TICI) scale.

Results

A total of 25 patients were included in the study. The mean age at baseline was 72.3 years old, and 52% of patients were female. Mean National Institutes of Health Stroke Scale score at admission was 16.4. Occlusion locations included the M1 segment of the middle cerebral artery (MCA) (60%), internal carotid artery terminus (20%), and M2 segment of MCA (16%). The average number of passes per intervention was 2.2. Successful reperfusion (TICI 2b, TICI 2c, and TICI 3) was achieved in 88% of patients.

Conclusions

This report of the first center to implement the CEREGLIDE™ 71 Intermediate Catheter for acute ischemic stroke demonstrated successful recanalization rates. This is largely attributed to the large inner diameter of the catheter, which results in higher aspiration force as well as improved trackability allowing for enhanced navigation through cerebrovascular anatomy.

Introduction

Stroke presently ranks as the fifth leading cause of death in the United States and stands as the leading cause of disability. ¹ Among the ∼795,000 strokes reported annually in the United States, 87% are identified as ischemic strokes and the vast majority are first-time attacks. ¹ From 1990 to 2019, the worldwide number of deaths due to ischemic stroke increased from 2.04 to 3.29 million, and projections suggest a further increase to 4.90 million by the year 2030. ²

Endovascular treatment (EVT) has become the standard of care for the treatment of patients with acute ischemic stroke (AIS) with large vessel occlusion (LVO).^3,4 Although most regional stroke centers are capable of administering intravenous thrombolysis, outcomes are markedly improved with EVT which is only offered at comprehensive stroke centers with endovascular ability. Commonly implicated vessels in patients with stroke due to LVO are typically the proximal large caliber vessels such as the internal carotid artery (ICA), and proximal segments of the middle cerebral artery (MCA). ⁵

Over the past several decades, numerous innovative devices and techniques have emerged within EVT, aimed at minimizing recanalization time and enhancing overall clinical and technical outcomes.^6,7 During mechanical thrombectomy (MT), an intermediate catheter is navigated through trans-femoral or trans-radial arterial access to the site of vascular occlusion to perform either direct aspiration or a combined technique with a stent retriever in order to recanalize the vessel. While MT has become the standard of care, the optimal first-line strategy, or combination thereof, remains a topic of controversy. Although the predominant focus of data for MT revolves around using stent retrievers as the first-line technique, there is evidence indicating that A Direct Aspiration First Pass Technique (ADAPT) is not only as effective as using stent retrievers but also quicker and more cost-effective.^8–10 Clinical trials such as the COMPASS (Contact Aspiration versus Stent Retriever for Successful Revascularization) trial demonstrated that ADAPT resulted in a functional outcome at 90 days that was not inferior, when compared to employing a stent retriever as the primary approach for MT. ¹⁰ The ASTER (Aspiration vs. Stent Retriever for Revascularization) trial demonstrated the non-superiority of ADAPT compared to stent retriever in terms of functional outcomes, with some studies suggesting advantages in procedural speed and reduced endothelial trauma^11–13. Additionally, postinterventional MRI studies have revealed indirect indications of vessel wall injury, with a higher incidence of injury observed in patients treated with a stent retriever compared to those undergoing direct aspiration. ¹⁴

Direct aspiration techniques have emerged as a cornerstone in MT, with their efficacy closely tied to advancements in catheter technology. Central to these advancements is the development of large-bore aspiration catheters, which deliver significantly enhanced aspiration force compared to their smaller-diameter counterparts. ¹⁵ This is particularly beneficial in cases of LVO. The aspiration force is directly influenced by the larger inner diameter (ID) of the aspiration catheter.^8,12 Historically, the application of direct aspiration for MT has faced limitations, due to the absence of catheters of sufficient size. These catheters need to generate enough aspiration force for thrombus removal while remaining flexible and soft to navigate the cerebral vasculature safely. ⁹ However, this limitation has been addressed with the introduction of a new generation of large-bore aspiration catheters. As a result, high-performance aspiration catheters are now available for swift and secure delivery to the intracranial circulation. These devices not only facilitate effective thrombus removal but also enhance procedural safety and efficiency. ¹⁶ In addition to aspiration force, the reliability, trackability and manipulability of the intermediate catheter play pivotal roles in MT procedures. To attain these features, device manufacturers modify the design of the catheters by adjusting the four elements that make up their structure: the inner liner, reinforcement structure, outer jacket, and hydrophilic coating. ¹⁷

The CEREGLIDE™ 71 Intermediate Catheter is an FDA-cleared catheter for use in MT for AIS. It is a variable stiffness, a single-lumen catheter with an ID of 0.071 inches, a hydrophilic coating, polytetrafluoroethylene liner, and an outer jacket composed of Pebax copolymer and Urethane. It features a stiff proximal shaft, which transitions into the flexible distal shaft to facilitate the advancement of the catheter into various types of anatomy. This catheter is optimized for effective direct aspiration and up to three stent retriever passes. The objective of this clinical study is to assess the characteristics and outcomes of EVT following the inaugural global use of the CEREGLIDE™ 71 Intermediate Catheter at our institution.

Materials and methods

Study design and patient selection

A retrospective, single-center study was conducted under IRB approval to evaluate the characteristics of MT using the CEREGLIDE™ 71 Intermediate Catheter as the primary intermediate catheter in cases of acute LVO. Following the first global use of the catheter at our institution in October 2023, all patients with anterior circulation LVO underwent MT with the CEREGLIDE™ 71 Intermediate Catheter. The study cohort included all consecutive patients diagnosed with AIS due to anterior LVO who underwent MT between October 2023 and May 2024 at one institution. Patients with posterior circulation occlusions or distal occlusions in the anterior circulation were not included in the study. LVO was defined as occlusion of the ICA, and the M1 and M2 segments of the MCA. ⁵ Given the retrospective study design, informed consent was waived and all data was anonymized.

Data collection

Data were extracted from the electronic medical record (EMR), including patient demographics (age and sex), National Institutes of Health Stroke Scale (NIHSS) scores at admission, administration of intravenous thrombolytics, occlusion location, number of passes, thrombectomy technique utilized, and recanalization outcomes. Recanalization success was assessed based on the Thrombolysis in Cerebral Infarction (TICI) score, with successful revascularization defined as TICI grades 2b, 2c, or 3. Data were reported as number of cases, means, and percentages.

Assessment and endovascular procedure:

Prior to EVT, all patients underwent a standardized imaging protocol consisting of non-contrast computed tomography (CT), CT angiography, and perfusion CT to confirm the presence of LVO. Upon detection of LVO, a multidisciplinary team including a vascular neurologist and a neuroendovascular surgeon evaluated each patient to determine eligibility for EVT. Patients eligible for intravenous thrombolysis were treated with Tenecteplase according to institutional protocols. MT procedures followed the institution's standardized workflow, including the use of general anesthesia when indicated. The CEREGLIDE™ 71 Intermediate Catheter was employed as the primary intermediate catheter for all thrombectomy procedures. Digital subtraction angiography (DSA) with contrast injection was used to visualize the cerebral vasculature including identification of arterial occlusions, collateral circulation, and degree of revascularization. The number of passes required for recanalization and the specific thrombectomy techniques (aspiration, stent retriever, and combined) were documented.

Outcome measures

Angiographic outcomes were assessed immediately post-procedure using the TICI scale to determine the degree of vessel recanalization. Clinical outcomes were evaluated using the NIHSS at baseline and during in-hospital follow-up. Long-term functional outcome data, such as the 90-day modified Rankin Scale (mRS), were not available.

Results

A total of 25 consecutive cases conducted by two surgeons from our center were included in this study. There were no significant differences in baseline characteristics. Patients in the cohort had a mean baseline age of 72.3 years. The gender distribution included 52% (n = 13) females, and 48% (n = 12) male.

On presentation, patients were assessed using the NIHSS, with the cohort exhibiting an average score of 16.4. Intravenous thrombolytic therapy with Tenecteplase was administered prior to MT in 28% (n = 7) of the patients, who were deemed eligible candidates in accordance with treatment protocols.

Procedural characteristics and technical outcomes

Upon gaining intravascular access, vessel anatomy, and patency was assessed using DSA. An M1 segment occlusion resulting in TICI 3 recanalization with the CEREGLIDE™ 71 is shown in Figure 1 with pre-aspiration and post-aspiration contrast injections. The most prevalent site of occlusion was the M1 segment of the MCA, affecting 60% (n = 15) of the patients. Occlusion of the ICA was observed in 20% (n = 5), while 16% (n = 4) presented with an occlusion in the M2 segment of the MCA. One patient (4%) exhibited a tandem occlusion involving both the ICA and MCA.

Figure 1.

Pre-aspiration and post-aspiration digital subtraction angiography (DSA).

Pre-aspiration DSA following initial contrast injection into the right internal carotid artery with anteroposterior (a) and lateral (b) projections in the arterial phase. The filling defect at the M1 segment of the middle cerebral artery is consistent with large vessel occlusion (white arrow). Post-aspiration DSA following mechanical thrombectomy with direct aspiration using the CEREGLIDE ™ 71 Intermediate Catheter. Right internal carotid artery contrast injection displays patency of the M1 segment of the middle cerebral artery in anteroposterior (c) and lateral (d) projections. Restored anterograde flow displays visualized M1 filling as well as bifurcation to the M2 and distal cortical branches consistent with TICI 3 recanalization.

MT was performed using techniques tailored to the anatomical and clinical considerations of each case. First, pass MT employed direct aspiration with the CEREGLIDE™ 71 Intermediate Catheter. Using the DSA roadmap, the catheter was able to be navigated to the proximal M1 segment in the case of an M1 occlusion (Figure 2). The average number of passes required to achieve satisfactory reperfusion was 2.2. The aspiration-only technique was employed in 28% (n = 7) of patients, while the combined aspiration and stent retriever technique was utilized in 72% (n = 18). Successful reperfusion, defined by achieving a TICI score of 2b, 2c, or 3, was attained in 88% (n = 22) of the cohort. A summary of baseline demographic characteristics, clinical presentation, occlusion details, procedural techniques, and reperfusion outcomes is provided in Table 1.

Figure 2.

Digital subtraction angiography roadmap.

Digital subtraction angiography roadmap, anteroposterior projection, with right internal carotid artery contrast injection. The roadmap demonstrates a right M1 occlusion with the distal tip of the CEREGLIDE™ 71 successfully positioned within the right proximal M1 segment of the middle cerebral artery (arrowhead).

Table 1.

Summary of data from the first center to implement the CEREGLIDE™ 71 Intermediate Catheter in mechanical thrombectomy for acute ischemic stroke (10/2023–5/2024).

Total number of cases	25 patients
Female	13 (52%)
Average age	72.3 years
Average NIHSS	16.4
IV thrombolytics use:	7 (28%)
Occlusion location	Tandem ICA/MCA occlusion: 1 (4%) ICA: 5 (20%) M1 MCA: 15 (60%) M2 MCA: 4 (16%)
Average number of passes	2.2
Thrombectomy technique	Aspiration only: 7 (28%) Aspiration and stent retriever: 18 (72%)
Recanalization rate	TICI 0: 1 (4%) TICI 1: 0 (0%) TICI 2A: 2 (8%) TICI 2B: 11 (44%) TICI 2C: 4 (16%) TICI 3: 7 (28%)
Success rate	Successful (TICI 2B, 2C, and 3): 22 (88%) Unsuccessful (TICI 0, 1, and 2A): 3 (12%)

NIHSS: National Institute of Health Stroke Scale; IV: intravenous; ICA: internal carotid artery; MCA: middle cerebral artery; TICI: thrombolysis in cerebral infarction scale.

Discussion

This retrospective single-center study constitutes the first comprehensive global report presenting data on the utilization of the CEREGLIDE™ 71 Intermediate Catheter during its first implementation for endovascular therapy in patients with AIS in the setting of LVO. Preliminary multicenter findings have been briefly reported in the past. ¹⁸ The present aim is to describe a single-center experience using a cohort of the first set of consecutive patients in which the catheter was used.

Effective EVT results in markedly enhanced clinical outcomes for emergent treatment of stroke due to LVO. Numerous studies have illustrated its effectiveness beyond the confines of strict randomized controlled trial inclusion criteria. ¹⁹ Despite the establishment of MT as the standard of care, there is still ongoing debate surrounding the optimal first-line strategy. Intermediate catheters, also known as aspiration catheters, play a major role in the success of MT, especially when ADAPT is employed. Consequently, MT procedures rely heavily on the choice of intermediate catheter. Each aspect of the catheter structure drives optimal function.

The cohort had an average age of 72.3 years reflecting an elderly population with a slight female predominance at 52%. The presenting NIHSS score was 16.4 depicting a major and disabling stroke burden. LVOs of the MCA comprised 76% of the cohort (Figure 1). This necessitates a deliverable catheter capable of smooth navigation in order to reach past the ICA terminus (Figure 2). This was especially advantageous in the singular case of a tandem ICA/MCA occlusion in which the variable stiffness of the device allowed for successful recanalization. The majority of the cases (72%) employed aspiration and stent retriever technique, however, direct aspiration was used during the first pass in each case. Through this first center experience, our results demonstrate a successful utilization of CEREGLIDE™ 71 with a profoundly favorable recanalization rate (TICI 2b, 2c, and 3) of 88%, with an average of 2.2 passes among the entire cohort (Table 1). These findings suggest that the catheter can be effectively integrated into routine MT workflows. Notably, Figure 1 depicts a representative case of a LVO in the M1 segment of the MCA. This was one of several cases in our series in which complete reperfusion (TICI 3) was successfully achieved, highlighting the device's effectiveness in navigation and delivering optimal angiographic outcomes.

The CEREGLIDE™ 71 has been optimized in aspiration, trackability, manipulability, support, and delivery. It has an optimal ID of 0.071″ that is large enough to result in a high aspiration force, but still maintain significant navigability, allowing the operator to successfully course through anatomically challenging or tortuous areas like the ophthalmic segment of the ICA. In one illustrative case involving an M1 occlusion, the catheter was successfully advanced into the proximal M1 segment, demonstrating the effective balance between size and navigability (Figure 2). As published literature on this intermediate catheter and its dynamics is severely limited, a review of the product specifications was conducted to highlight our experience with its various features (CERENOVUS Johnson&Johnson MedTech, product specifications, jnjmedtech.com/en-US/product/cereglide-71-with-trucourse). The catheter employs TruCourse™ proprietary technology which allows for smooth navigation due to improved catheter flexibility. Furthermore, its 55 cm of hydrophilic coating near the distal soft tip is complemented by a more rigid body to provide accurate advancement of the catheter without risking trauma to the vessel endothelia. Other large bore aspiration catheters that are commonly used include React 71 with an ID of 0.071″ (Medtronic), Sofia Plus with an ID of 0.070″ (Terumo Neuro), Catalyst 6 with an ID of 0.060″ (Stryker), and Zoom 71 with an ID of 0.071″ (Imperative Care). The product specifications disclose that the CEREGLIDE™ 71 offers a greater trackability compared to the first three, but lower than Zoom 71 based on silicone flow model experimental testing. Notably, the effective ID of Zoom 71 is 0.076″ due to the angled-tip design not present in the present study device. Compared to Sofia Plus and React 71, the CEREGLIDE™ 71 also offers improved delivery with more resistance to kinking. However, the catheter is limited by the location of the stroke as its distal outer diameter of 0.0820 inches does make safely entering distal vasculature beyond the M2 segment less favorable, compared to lower profile catheters like Catalyst 6 ID (0.060″) for distal recanalization.

Flow model studies published prior to the advent of the CEREGLIDE™ 71 have evaluated the performance of other large-bore aspiration catheters. A study using a vascular phantom compared the Sofia 6, React 71, Jet 7, Catalyst 7, and Embovac 071 catheters, which have an ID ranging from 0.068″ to 0.072″. Trackability, aspiration flow rate, and tensile strength were assessed. The findings indicated that while the Jet 7 exhibited the highest aspiration flow rate due to its larger ID (0.072″), the React 71 and Sofia 6 demonstrated superior trackability, which is crucial for navigating tortuous vasculature. ²⁰

In this study, CEREGLIDE™ 71 was successfully used with both ADAPT (28%) and combined approaches (72%). Despite the establishment of MT as the standard of care, there is still ongoing debate surrounding the optimal first-line strategy for thrombectomy. Several studies have compared direct aspiration versus stent retriever first-line technique for the treatment of anterior circulation LVO. The COMPASS trial demonstrated that ADAPT resulted in a functional outcome at 90 days that was not inferior when compared to employing a stent retriever as the primary approach for thrombectomy. ¹⁰ Furthermore, opting for direct aspiration over stent retriever as a first-line strategy has been reported to lead to a reduction in both the cost of the device and procedural time.^10,11 The ASTER trial reported similar findings in that contact aspiration was not superior to stent retriever in achieving successful recanalization rates, but supported the notion that both approaches yield comparable outcomes.^11,13 A recent systematic review and meta-analysis by Zhang et al. ²¹ reported that ADAPT also resulted in similar clinical outcomes compared to stent retrievers but more likely required additional therapy. Thus large bore aspiration catheters like CEREGLIDE™ 71 that have optimized their ADAPT capability are ideal. CEREGLIDE™ 71 can still be utilized with combined strategies as well, as it remains compatible with stent retrievers like EMBOTRAP™ III. Here, it also demonstrated a low number of average passes (2.2) thereby reducing the risk of vessel trauma, and it can be used up to three passes without compromising its integrity.

Despite the valuable insights provided by this study, limitations include the small sample size of 25 patients which may limit the generalizability of these initial findings. The absence of a control group or randomization prevents direct comparison between this intermediate catheter and similar devices in its class. This also limits the comparison between direct aspiration and stent retriever usage in the cohort. The heterogeneity in treatment approaches, particularly the varied use of aspiration-only versus combined techniques, may have introduced variability that affects the interpretation of results, although the study is strengthened by first-pass aspiration in each case. Our outcome measures primarily focus on successful reperfusion rates (TICI 2b, TICI 2c, and TICI 3), without comprehensive information on long-term functional outcomes. Therefore, future research should aim to address long-term follow-up to validate and expand upon the findings observed in this study.

Conclusions

Results from the first global deployment of the CEREGLIDE™ 71 intermediate catheter show successful recanalization rates in EVT of AIS in the setting of LVO. The catheter has been optimized in trackability, support, delivery, and aspiration, especially for the ADAPT technique.