Status:
COMPLETED
Safety Study of a Bioresorbable Coronary Stent
Lead Sponsor:
REVA Medical, Inc.
Conditions:
Myocardial Ischemia
Coronary Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.
Detailed Description
Today, coronary artery disease is often treated by placing a metal stent inside the vessel that serves as a permanent scaffold. However, it is hypothesized that the stent is no longer needed once the ...
Eligibility Criteria
Inclusion
- Evidence of myocardial ischemia or a positive functional study.
- Normal CK-MB.
- Target lesion must be located in a native coronary artery where target vessel diameter is ≥ 2.9 mm and ≤ 3.3 mm and target lesion length is ≤ 12 mm, both assessed by on-line QCA and IVUS
- Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 2.
- Staged procedures are allowed in non-target vessels \>24 hours before or \> 30 days after REVA stent implantation
Exclusion
- A myocardial infarction (CK-MB or Troponin \> 3 times normal) within 72 hours of the procedure, has signs or symptoms of an ongoing myocardial infarction or has any visible thrombus
- Unprotected left main coronary disease with \>50% stenosis
- The target vessel is totally occluded (TIMI Flow 0 to 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 segment supplied by distal graft
- Target lesion has possible or definite thrombus
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01262703
Start Date
December 1 2011
End Date
December 1 2018
Last Update
March 29 2023
Active Locations (1)
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1
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil