ABSORB PHYSIOLOGY Clinical Investigation

Status Terminated

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01308346
Study type	Interventional
Source	Abbott Vascular
Contact
Status	Terminated
Phase	N/A
Start date	November 2011
Completion date	April 2013

View Details

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