Safety Study of a Bioresorbable Coronary Stent

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Artery Stenosis; Cardiovascular Disease; Coronary Disease; Coronary Restenosis
• Interventions: Device: ReZolve Stent

• Registration Number: NCT01262703
• Lead Sponsor: REVA Medical, Inc.

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.

Study Timeline

• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Study Start: 2011-12
• Primary Completion: 2013-10
• Study Completion: 2018-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
REVA Medical ReZolve Stent	ReZolve Stent	ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Primary Outcome Measures

Name	Time	Method
Ischemia-driven Target Lesion Revascularization (TLR)	6 months	Defined as any clinically-driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.

Secondary Outcome Measures

Name	Time	Method
QCA & IVUS derived parameters	12 months	Late Loss, Restenosis Rate, %DS, MLD \& Neointimal Volume
Major Adverse Coronary Events	60 months	Major Adverse Cardiac Events - Combined events consisting of death, Myocardial Infarction (Q-Wave, Non Q-wave: CPK \> 2xULN + MB\>ULN) (MI), and target vessel revascularization (TVR).
Procedural and Technical Success	Acute	percentage of patients with angiographic success successful delivery and deployment of the device

Trial Locations

Locations (1)

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 Sao Paulo, Brazil