Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment fantom sirolimus-eluting coronary bioresorbable scaffold
Sponsor REVA Medical, Inc.
Start date March 2015
End date April 2016
Trial size 220 participants
Trial identifier NCT02539966, HCT6200

Summary

The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)
fantom sirolimus-eluting coronary bioresorbable scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
(Experimental)
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)
fantom sirolimus-eluting coronary bioresorbable scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease

Primary Outcomes

Measure
Major Adverse Cardiac Events (MACE) - Cohort A and B
time frame: 6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
time frame: 6 months

Secondary Outcomes

Measure
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
time frame: 9 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
time frame: 6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
time frame: 9 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
time frame: 6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
time frame: 9 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
time frame: 6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
time frame: 9 months
Major Adverse Cardiac Events (MACE) - Cohort A and B
time frame: 12, 24, 36, 48 and 60 months
Target Lesion Revascularization (TLR) - Cohort A and B
time frame: 12, 24, 36, 48 and 60 months
Target Vessel Revascularization (TVR) - Cohort A and B
time frame: 12, 24, 36, 48 and 60 months
Target Vessel Failure (TVF) - Cohort A and B
time frame: 12, 24, 36, 48 and 60 months
Acute Technical Success - Cohort A and B
time frame: Day 0
Procedural Success - Cohort A and B
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient has evidence of myocardial ischemia or a positive functional study - Target lesion has a visually estimated stenosis of ≥50% and <100% - Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.5mm and ≤ 3.5mm - Target lesion length must be ≤ 20mm - Baseline TIMI flow ≥ 2 Exclusion Criteria: - 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. - Patient has a left ventricular ejection fraction < 40% - Patient has unprotected left main coronary disease with ≥50% stenosis - The target vessel is totally occluded (TIMI Flow 0 or 1) - Target lesion involves a bifurcation (a lesion with a side branch ≥ 1.5 mm in diameter containing a ≥ 50% stenosis). - Target lesion is located within a bypass graft - Target lesion has possible or definite thrombus

Additional Information

Official title Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Principal investigator Alexandre Abizaid, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by REVA Medical, Inc..