. 2012 Jul 19;14(5):626–634. doi: 10.1007/s11886-012-0295-5

Table 1.

Aim, design, and primary and secondary end-points of the ongoing clinical studies

Device	Name	Aim	Design	Number of patients	Follow-up	Primary end-points	Secondary-end points
DREAMS	BIOSOLVE-I	Assess the safety and efficacy of DREAMS	Prospective, open label	46	3 years	1. Target lesion failure at 6 and 12 months	1. LLL, binary restenosis and scaffold stenosis at 6 and 12 months
DREAMS	BIOSOLVE-I	Assess the safety and efficacy of DREAMS	Prospective, open label	46	3 years	1. Target lesion failure at 6 and 12 months	4. Target lesion failure at 6, 12, 24, and 36 months
Abbott Vascular BRS 1.1	ABSORB Cohort B	Assess the safety and effectiveness of the BRS 1.1	Prospective, open label	101	5 years	-	1. LLL at 6 months 1, 2, and 3 years
							2. Diameter stenosis at 6 months, 1 and 2 years
							3. MACE and TLR at 30 days 6, 9 months 1, 2, 3, 4, and 5 years
Abbott Vascular BRS 1.1	ABSORB Extend	Assess the safety and performance of the BRS 1.1	Registry	1000	5 years	1. Acute success	1. Scaffold and lumen area, MLA and struts apposition assessed by OCT at 2 years
						2. No other primary end points – all outcomes are of equal weight	2. LLL, MLD, % diameter stenosis on angiography at 2 years
							4. IVUS evaluation including vessel and scaffold area, MLA, volume obstruction
							3. MACE and TLR at 30, days, 6 months 1, 2, and 3 years
Abbott Vascular BRS 1.1	ABSORB II	Compare the safety and efficacy of the BRS 1.1 to Xience Prime	Prospective, randomized control trial	501	3 years	1. TRL at 6 months	1. Device – procedural success
						2. Vasomotion of the treated lesion at 2 years	2. Death, MI, MACE at 30, 180 days, 1, 2, and 3 years
							3. TLR, TVR, scaffold thrombosis at 30, 180 days, 1, 2, and 3 years
Abbott Vascular BRS 1.1	ABSORB Physiology	Evaluate the effect of the BRS 1.1 and the Xience DES on vessel physiology postprocedure and at 2 years follow-up	Randomized single blind	36	2 years	1. Coronary artery endothelial response postprocedure	1. Vessel impedance, compliance, distensibility and wall shear stress, postprocedure and at 2 years follow-up
Abbott Vascular BRS 1.1	ABSORB Physiology		Randomized single blind	36	2 years	1. Coronary artery endothelial response postprocedure	2. Cardiac and all cause mortality, MI, MACE, TVR, TLR and stent thrombosis at 6 months, 1 and 2 years
ReZolve	RESTORE	Examine the safety and efficacy of the ReZolve BRS	Prospective, open label	50	5 years	1. TLR at 6 months	1. Procedural success
						2. QCA and IVUS measurements at 12 months	2. LLL, restenosis rate, MLD, neointima volume at 12 months
							3. MACE at 12 months
ReZolve	ReZolve CE Mark	Demonstrate non-inferiority of the ReZolve BRS against a DES	Randomized, trial	350	5 years	1. Clinical follow-up at 1, 6, and 12 months and then annually for up to 5 years	1. LLL
ReZolve	ReZolve CE Mark		Randomized, trial	350	5 years	2. Invasive imaging at 9 and 12 months	2. MACE
DeSolve	DeSolve I	Evaluate the safety and efficacy of DeSolve BRS	Prospective, open label	16	5 years	1. LLL at 6 months	1. Device and procedural success
							2. MACE, TLR, TVR and stent thrombosis at 1, 6, 12 months, 2 and 5 years
							3. OCT measurements at 6 months
DeSolve	DeSolve NX	Evaluate the safety and efficacy of DeSolve BRS	Prospective, open label	120	5 years	1. Procedural success	-
						2. MACE at 1, 6, and 12 months, 2, 3, 4, and 5 years
						3. LLL at 6 months

LLL, late lumen loss; BRS, bioresorbable scaffold; MACE, major adverse cardiac events; TLR, target lesion revascularization; MLA, minimal lumen area; MLD, minimal luminal diameter; OCT, optical coherence tomography; IVUS, intravascular ultrasound; MI, myocardial infarction; TVR, target vessel revascularization; QCA, quantitative coronary angiography; CE, Conformité Européenne; DES, drug eluting stent