Table 3. . Clinical studies with COBRA-PzF.
Study | Publication year | Study participants | Follow-up duration | Study design | End point findings | Ref. |
---|---|---|---|---|---|---|
Maillard et al. | 2017 | 100 patients (38% with ACS); 151 lesions | 1 year | Single-center study | Primary end point: target vessel failure 12%, including 2% mortality, 5% periprocedural MI and 5% target lesion revascularization |
[35] |
Cutlip et al. | 2017 | 296 patients (31% with ACS); 300 lesions | 9 months | Multi-center study | Primary end point: target vessel failure 11.5%, including 0.3% cardiac death, 7.0% MI (1% spontaneous MI), 5.9% target vessel revascularization Secondary end point: angiographic in-stent late lumen loss 0.84 ± 0.48 mm |
[40] |
Maillard et al. | 2020 | 940 patients (47% with ACS; 62% with high bleeding risk); 1229 lesions | 1 year | Multi-center study | Primary end point: Major adverse cardiac event rate of 9.0%, including 3.7% cardiac death, 4.8% MI, 4.3% target lesion revascularization Secondary end point: definite stent thrombosis in 0.7% |
[41] |
Maillard et al. | 2020 | 77 patients with high bleeding risk (18.2% with ACS); 120 lesions | 1 year | Single-center study | Primary end point: treatment with clopidogrel for 1 month, followed by aspirin monotherapy did not result in stent thrombosis Secondary end point: major adverse cardiac events rate of 3.8%, including 0% cardiac death, 0% MI, 3.8% target lesion revascularization |
[42] |
ACS: Acute coronary syndrome; MI: Myocardial infarction.