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Clinical Trials/NCT02512003
NCT02512003
Completed
Not Applicable

Pilot Study of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold

REVA Medical, Inc.2 sites in 2 countries7 target enrollmentDecember 2014
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ConditionsCoronary Artery Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
REVA Medical, Inc.
Enrollment
7
Locations
2
Primary Endpoint
Ischemia-driven Target Lesion Revascularization (TLR)
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
April 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Ischemia-driven Target Lesion Revascularization (TLR)

Time Frame: 4 months

Percent of Patients with TLR at 4 months

Secondary Outcomes

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

Study Sites (2)

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