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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

Most important General Inclusion Criteria
-Participant must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia with a positive functional study).
-Participant must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.;Angiographic Inclusion Criteria
1. A single de novo native coronary artery lesion suitable to be treated by either a BVS or a mDES.
2. Target lesion must be located in a native coronary artery in which the mean proximal and distal vessel diameter of the target lesion (Dmean) fall within the range of >= 2.25 mm and <= 3.25 mm and the target lesion length measures <= 22 mm as assessed by IVUS.
3. Target lesion must be located in the main branch of a major epicardial vessel (i.e., LAD, LCX, or RCA) with a visually estimated diameter stenosis of >= 50% and < 100% with a TIMI flow of >= 1.
4. Participant must have an additional angiographically smooth (< 40% diameter stenosis) non-target vessel to act as an intra-participant control vessel (self-control vessel). The self-control vessel must be the main branch of a major epicardial vessel (i.e., LAD, LCX, or RCA).
5. Coronary anatomy must be suitable for IVUS, OCT, and pressure and flow wire instrumentation.

Exclusion Criteria

Most important general exclusion criteria
1. Participant has a known diagnosis of spontaneous acute myocardial infarction (AMI) within 14 days preceding the index procedure.
2. Participant has high-risk acute coronary syndrome (e.g., dynamic ST-T wave change on ECG or recurrent chest pain/nitrate-unresponsive prolonged chest pain at rest within 48 hours prior to the index procedure).
3. Participant has any evidence of myocardial infarct in the territory subtended by the proposed target vessel or self-control vessel.
4. Participant has current unstable arrhythmias.
5. Participant has chronic atrial fibrillation.
6. Participant has a known left ventricular ejection fraction (LVEF) < 40%.
7. Participant has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
8. Participant has previously had CABG or mitral or aortic valve repair/replacement.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Outcome Measures<br /><br>Coronary Artery Endothelial Responsiveness to:<br /><br>- Flow-mediated dilation (FMD) induced by pacing and hand-grip<br /><br>- Direct (intra-coronary) infusion of acetylcholine<br /><br><br /><br>Clinical Outcomes<br /><br>Standard percutaneous coronary intervention (PCI)-type clinical outcomes will<br /><br>be captured (Refer to Section 4.4.2 for details).</p><br>

Secondary Outcome Measures