The objective of the ABSORB PHYSIOLOGY is to evaluate the following in participants undergoing coronary artery scaffolding/stenting for significant coronary artery disease:• The acute (post-implantation) effect of an implanted BVS or mDES on…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Outcome Measures
Coronary Artery Endothelial Responsiveness to:
- Flow-mediated dilation (FMD) induced by pacing and hand-grip
- Direct (intra-coronary) infusion of acetylcholine
Clinical Outcomes
Standard percutaneous coronary intervention (PCI)-type clinical outcomes will
be captured (Refer to Section 4.4.2 for details).
Secondary outcome
Secondary Outcome Measures
Coronary artery cross-sectional compliance and cross-sectional distensibility.
Background summary
The ABSORB PHYSIOLOGY Clinical Investigation is a prospective, randomized study
comparing the coronary artery blood flow and physiological responsiveness of
the target artery between participants implanted with an Abbott Vascular
Everolimus-Eluting Bioresorbable Vascular Scaffold (BVS) or a traditional
metallic drug-eluting stent (mDES) for a single, de novo native coronary artery
lesion.
After the resorption of the Bioresorbable Vascular Scaffold (BVS), there will
be a return towards a physiological-like behavior of the previously
stented/scaffolded segment and a greater likelihood that the target artery may
be able to accommodate increased coronary blood flow in comparison to
traditional mDES by showing an improved response to endothelial flow related
response. In contrast, this hypothesized benefit of a bioresorbable scaffold
will not occur in arterial segments stented with a rigid metal stent that
persists.
ABSORB PHYSIOLOGY will evaluate the short and long-term effects of an implanted
BVS or mDES on coronary artery blood flow and physiological responsiveness of
the target artery to test the hypothesis.
Study objective
The objective of the ABSORB PHYSIOLOGY is to evaluate the following in
participants undergoing coronary artery scaffolding/stenting for significant
coronary artery disease:
• The acute (post-implantation) effect of an implanted BVS or 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
Study design
ABSORB PHYSIOLOGY is a prospective, randomized, single-blinded, multi-center
clinical investigation that will enroll a minimum of 36 participants at 6 to 8
sites. Participants with a single, de novo native coronary lesion suitable to
be treated with either a BVS or an mDES and having an additional
angiographically smooth (< 40% diameter stenosis) control vessel will be
enrolled. Participants will be randomized 2:1 to BVS or mDES treatment. The BVS
arm will enroll a minimum of 24 participants and the mDES arm will enroll a
minimum of 12 participants.
Physiology studies evaluating physiological responsiveness of the coronary
artery and coronary blood flow will be performed in both the target vessel and
the control vessel for all participants following the PCI procedure (baseline)
and at 2 years. The angiographically smooth, nonintervened control vessel will
be used as an intra-participant control (self-control vessel) to eliminate
potential medical treatment/disease progression effects. Comparisons will be
made between the target vessel and the self-control vessel within participants
and between participants undergoing BVS or mDES treatment, as well as across
different time points.
Intervention
Placement of the scaffold will not differ from a routine stent procedure.
Post-placement of the scaffold includes IVUS, OCT and physiological tests.
Apart from twice a telephone follow-up (or outpatients), an additional angio
will be done at 2 years , including IVUS, OCT and physiological tests.
Study burden and risks
The potential risks do not differ from the risks associated with routine stent
procedures as described in the brochure of the Dutch Heart Foundation.
Death-0.2-0.5%
Myocardial infarction during the intervention
Hematoma (groin/ arterial sheath)
Major bleeding caused by the administration of anticoagulants during and after
treatment
In addition to this, is it important to note that patients undergo during the
follow-up phase a repeat angio. The risk of this repeat angio is also mentioned
in the brochure of the Heart Foundation.
Park Lane, Culliganlaan 2B
1831 Diegem
BE
Park Lane, Culliganlaan 2B
1831 Diegem
BE
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01308346 |
| CCMO | NL37887.101.11 |