Insufficient blood flow tissue of the heart muscle
Conditions
Interventions
Implantation of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold.
Sponsors
REVA Medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * The patient is * 18 years of age * The subject must have evidence of myocardial ischemia (e.g. stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and
Exclusion criteria
Exclusion criteria: * The patient has a known allergy, intolerance, or is contraindicated to aspirin, both heparin and bivalirudin, clopidogrel and/or contrast media, and cannot be adequately pre-medicated * The patient has experienced an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the procedure and either CK-MB or Troponin has not returned to within 2X ULN. Note: In the event that CK-MB is not measured prior to treatment, the patient will be considered to have met this enrollment criteria provided that the Troponin assessment is within 2X ULN and a blood sample is drawn prior to the procedure; the CK-MB analysis must then be performed post-procedure * The patient is currently experiencing clinical symptoms consistent with AMI * The patient has a left ventricular ejection fraction of 30 days after REVA scaffold implantation. If a non-target lesion requires treatment during the index procedure, the non-target lesion should be treated first * The patient has unprotected left main coronary disease with * 50% stenosis * The patient has a significant (* 50%) untreated stenosis proximal or distal to the target lesion * The patient has a scaffold(s) or stent located within 3 mm of the target lesion borders * The target vessel is totally occluded (TIMI Flow 0 to 1) * Excessive proximal tortuosity, vessel hinging at the lesion location or lesion angulation, such that in the operator*s judgment it is unlikely that the REVA Bioresorbable Coronary Scaffold or a standard scaffold could be delivered and/or expanded * The patient is currently participating in another investigational drug or device trial that has not completed the entire follow-up period * The patient has a co-morbidity, which reduces life expectancy to * 24 months, or factors making clinical follow-up difficult * The patient has: - Known hepatic impairment (Liver function tests (SGOT, SGPT, and ALT) >3 times normal) - Known impaired renal function (serum creatinine * 2.5 mg/dL) - A platelet count 700,000 cells/mm3 * The patient has a history of stroke (CVA) or TIA within the prior 6 months * The patient has an active peptic ulcer or upper GI bleeding within the prior 6 months * The patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions * The patient is a woman that is pregnant or lactating * Target lesion ostial (within 3mm of vessel origin) * Target lesion has moderate to severe calcification * Target segment has side branches or a bifurcation > 1.5 mm in diameter * Target lesion is located within an arterial bypass graft conduit or saphenous vein graft * Target lesion is located within a previously stented region * Target lesion is located within a segment supplied by distal graft * Target lesion has possible or definite thrombus * The patient is currentl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events (MACE) and Late Lumen Loss at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| All Cohort A Patients - QCA derived parameters at 6 -0/+ 1 month (e.g. Late Loss, Restenosis Rate, %DS & MLD) - IVUS & OCT imaging on a subset of patients at 6 -0/+ 1 month Up to 25 Cohort A Patients - QCA derived parameters at 24 -0/+ 1 month (e.g. Late Loss, Restenosis Rate, %DS & MLD) - IVUS & OCT imaging on a subset of patients at 24 -0/+ 1 month - Dual Source CT Scan All Cohort B Patients - QCA derived parameters at 9 -0/+ 1 month (e.g. Late Loss, Restenosis Rate, %DS & MLD) - IVUS & OCT imaging on a subset of patients at 9 -0/+ 1 month Up to 25 Cohort B Patients - QCA derived parameters at 48 -0/+ 1 month (e.g. Late Loss, Restenosis Rate, %DS & MLD) - IVUS & OCT imaging on a subset of patients at 48 -0/+ 1 month - Dual Source CT Scan All Patients - MACE through 60 months - TLR, TVR and TVF through 60 months post procedure - Procedural success * percentage of patients with angiographic success (final diameter stenosis | — |
Countries
Netherlands
Outcome results
None listed