NCT01308346

ABSORB PHYSIOLOGY Clinical Investigation

ABSORB PHYSIOLOGY Clinical Investigation: Clinical Evaluation of the Short and Long-Term Effects of the Abbott Vascular Everolimus-Eluting Bioresorbable Vascular Scaffold on Coronary Artery Blood Flow and Physiological Responsiveness

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The target enrollment goal for the trial was to enroll 36 subjects. However due to a challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the trial was initiated in June 2011. To evaluate the following in participants undergoing coronary artery scaffolding/stenting for significant coronary artery disease: * The acute (post-implantation) effect of an implanted bioresorbable vascular scaffold (BVS) or metallic drug eluting stent (mDES) on coronary blood flow and physiological responsiveness of the target coronary artery * The long-term (2 years) effect of an implanted BVS or mDES on coronary blood flow and physiological responsiveness of the target coronary artery

Detailed description

* Prospective, randomized, single-blinded, multi-center clinical investigation comparing target vessel and non-intervened, self-control vessel within participants and between participants undergoing BVS or mDES deployment for the treatment of a single de novo native coronary artery lesion * The investigation will include two arms: * Study device (BVS) arm: Abbott Vascular's Everolimus-Eluting Bioresorbable Vascular Scaffold * Control device (mDES) arm: Abbott Vascular's Everolimus-Eluting XIENCE V or XIENCE PRIME

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)	Bioabsorbable Everolimus Eluting Coronary Stent
DEVICE	XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)	XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-03-04
• Last updated: 2013-05-07

Locations

6 sites across 4 countries: Australia, China, Netherlands, Singapore