TABLE IV.

Stents with surface modification at the nanoscale in clinical trials.

Stent	Clinical trial	Clinical endpoints	Result	References
Titan (Hexacath, France) titanium nitride oxide coating	TITAX AMI	MACE (16.4% vs 25.1%) and 5-year rates of cardiac death (1.9% vs 5.7%), recurrent MI (8.4% vs 18.0%) and rate of definite ST (0.9% vs 7.1%) were significantly lower in patients with TiNOx stent compared to Paclitaxel eluting stent (PES).	Better clinical outcome of TiNOx stent vs PES in patients with acute myocardial infarction	261
	BASE ACS	At 5-year follow-up, TiNOx stent was non-inferior to everolimus eluting stent (EES) for primary endpoint of MACE (14.4% vs 17.8%). The rate of non-fatal MI was lower in TiNOx stent group (5.9% vs 9.7%) and the rates of cardiac death (2.8% vs 3.8%) and ischemia-driven TLR (8.3% vs 9.9%) were comparable for both groups.	Better clinical outcome and non-inferiority of TiNOx stent vs EES in patients with acute myocardial infarction	262
	TIDES-ACS	TiNOx stents were associated with lower rates of cardiac death (0.6% vs. 2.6%) and MI (2.2% vs. 5.0%) than everolimus eluting stent (EES) at 18 months of follow-up.	TiNOx-coated stents were non-inferior to platinum–chromium–based biodegradable polymer EES at 12 months	263
MOMO (Japan Stent Technology) Diamond-like carbon coating	Multi-center, non-randomized clinical trial	No myocardial infarction, stent thrombosis, or cardiac death were observed in patients with MOMO stent. Binary restenosis was 12.5% (n = 5), and the LLL was 0.54 ± 0.3 mm.	Safety and feasibility of MOMO cobalt–chromium carbon-coated stent	264
		No in-stent thrombosis or myocardial infarction was observed in patients with MOMO stent. The binary restenosis rate at the 6-month was 10.5 % for MOMO stent, which is lower than commercially available bare-metal stents (BMS).	Non-inferiority over commercial BMS	265
SiC-coated stent	Tenax-vs Nir-stent Study	MACE occurred in 12% of Tenax recipients and 14.3% of Nir recipients. Premature target lesion revascularization was performed in 6.9% patients in Tenax group and 5.1% patients in Nir group.	Both SiC-coated (Tenax) and non-coated (Nir) stents had low rate of MACE, with no definite superiority of any of the devices.	266
		Target lesion revascularization was performed in 2% of Tenax group and 1.6% of Nir group and subacute thrombosis was observed in 0.8% of Tenax patients.	No advantage of the SiC-coated stent over stainless steel stent with regard to clinical and angiographic restenosis rates	267
SiO2 coated stent	First-in-man trial	Angiographic in-stent LLL was 0.77 ± 0.44 mm, and binary restenosis occurred in 33.3% of lesions. At 12 months, cardiac death, target vessel myocardial infarction, and target lesion revascularization rate was 33.3%.	In contrast with the preclinical study, the SiO2 coated stent did not efficiently suppress neointimal hyperplasia in humans in this trial.	268
COBRA Pz-F stent (Celenova Biosciences Inc.) Nanothin Polyzene-F coating	One-year follow-up	Target vessel failure (composite of all-cause mortality, myocardial infarction or target vessel revascularization) rate was 12%. There were no cases of definite stent thrombosis.	The COBRA PzF stent was safe and effective and was associated with excellent clinical outcomes.	271
VESTAsync drug eluting stent (MIV Therapeutics Inc.) Nanothin-microporous hydroxyapatite surface coating	VESTASYNC I trial	In-stent LL and percentage neointimal hyperplasia were 0.3 ± 0.25 mm and 2.6% ± 2.2%, respectively, with a nonsignificant increase at 9 months (0.36 ± 0.23 mm and 4.0% ± 2.2%, respectively). There were no MACE at 1 year follow-up.	VESTAsync-eluting stent was effective in reducing LL and neointimal hyperplasia at 4 and 9 months.	274, 275
Nano+ (Lepu Medical Technology) Nanoporous polymer-free SS stent eluting sirolimus	Nanotrial	Nano+ was non-inferior to durable-polymer DES (SES) at primary endpoint of 9 months. The incidence of MACE in the Nano+ group (7.6%) was comparable to SES group (5.9%) at 2 years follow-up. The frequency of cardiac death (0.8% vs. 0.7%) and stent thrombosis (0.8% vs. 1.5%,) was low for both Nano+ and SES.	Nano+ showed similar safety and efficacy compared with SES in the treatment of patients with de novo coronary artery lesions.	279
		The 1-year Target Lesion Failure rate was 3.1% with clinically driven TLR rates (1.3%), cardiac death (1.8%) and MI (0.4%). ST occurred in 0.4% of patients.	The 1-year clinical outcomes for Nano+ polymer-free SES implantation were excellent	280
BICARE (Lepu Medical Technology) Nanoporous polymer-free SS stent eluting dual drugs sirolimus and probucol	First-in-human trial	At 4 months, angiographic in-stent late loss was 0.14 ± 0.19 mm, and the in-stent binary restenosis rate was 3.1% and complete strut coverage was 98.2%. At 18 months, TLF occurred in 9.4% patients with no adverse safety events.	The preliminary feasibility and safety of polymer-free, dual- drug eluting stent, without any adverse safety events and favorable suppression of neointimal hyperplasia.	281