Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment fantom scaffold
Sponsor REVA Medical, Inc.
Start date December 2014
End date July 2015
Trial size 7 participants
Trial identifier NCT02512003, HCT6000

Summary

The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
fantom scaffold

Primary Outcomes

Measure
Ischemia-driven Target Lesion Revascularization (TLR)
time frame: 4 months

Secondary Outcomes

Measure
Quantitative Coronary Angiography (QCA) derived parameters
time frame: 4 months
Quantitative Coronary Angiography (QCA) derived parameters
time frame: 4 months
Quantitative Coronary Angiography (QCA) derived parameters
time frame: 4 months
Quantitative Coronary Angiography (QCA) derived parameters
time frame: 4 months
Quantitative Coronary Angiography (QCA) derived parameters
time frame: 4 months
Intravascular Ultrasound (IVUS) derived parameters
time frame: 4 months
Intravascular Ultrasound (IVUS) derived parameters
time frame: 4 months
Intravascular Ultrasound (IVUS) derived parameters
time frame: 4 months
Intravascular Ultrasound (IVUS) derived parameters
time frame: 4 months
Intravascular Ultrasound (IVUS) derived parameters
time frame: 4 months
Major Adverse Cardiac Events
time frame: 12, 24, 36, 48 and 60 months
Target Lesion Revascularization (TLR)
time frame: 12, 24, 36, 48 and 60 months
Target Vessel Revascularization
time frame: 12, 24, 36, 48 and 60 months
Target Vessel Failure (TVF)
time frame: 12, 24, 36, 48 and 60 months
Acute Technical Success
time frame: Day 0
Procedural Success
time frame: 30 days
Optical Coherence Tomography (OCT) Imaging on a Subset of Patients
time frame: 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient has evidence of myocardial ischemia or a positive functional study - Patient has a normal CK-MB - 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 ≥ 2.7mm and ≤ 3.3mm - Target lesion length must be ≤ 14mm Exclusion Criteria: - Patient has experienced a myocardial infarction (CK-MB or Troponin > 5 X ULN) within 72 hours of the procedure - Patient has a left ventricular ejection fraction < 25% - Patient has unprotected lest 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 ≥ 2.0 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 Pilot Study of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by REVA Medical, Inc..