Safety Study of a Bioresorbable Coronary Stent

NCT ID: NCT01262703

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2018-12-31

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 artery has healed. This study will evaluate the safety of a bioresorbable (non-permanent) stent for the treatment of coronary artery disease. The stent is designed to restore blood flow to the artery which allows the artery to remodel (heal), and then resorb from the body. The stent supports the vessel during the critical 90-day healing process, and then gradually resorbs and is cleared from the body.

Conditions

Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Cardiovascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

REVA Medical ReZolve Stent

ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Group Type: EXPERIMENTAL

ReZolve Stent

Intervention Type: DEVICE

ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Interventions

ReZolve Stent

ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

REVA Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre Abizaid, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardiologia

Locations

Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

HCT1000

Identifier Type: -

Identifier Source: org_study_id