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Safety Study of a Bioresorbable Coronary Stent (RESTORE)

Primary Purpose

Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

ReZolve Stent

About this trial

This is an interventional treatment trial for Myocardial Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Instituto Dante Pazzanese de Cardiologia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

REVA Medical ReZolve Stent

Arm Description

ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Outcomes

Primary Outcome Measures

Ischemia-driven Target Lesion Revascularization (TLR)

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

QCA & IVUS derived parameters

Late Loss, Restenosis Rate, %DS, MLD & Neointimal Volume

Major Adverse Coronary Events

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

percentage of patients with angiographic success successful delivery and deployment of the device

Full Information

NCT ID

NCT01262703

First Posted

December 16, 2010

Last Updated

March 27, 2023

Sponsor

REVA Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01262703

Brief Title

Safety Study of a Bioresorbable Coronary Stent

Acronym

RESTORE

Official Title

Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

December 2011 (Actual)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

REVA Medical, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

REVA Medical ReZolve Stent

Arm Type

Experimental

Arm Description

ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Intervention Type

Device

Intervention Name(s)

ReZolve Stent

Intervention Description

ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Primary Outcome Measure Information:

Title

Ischemia-driven Target Lesion Revascularization (TLR)

Description

Defined as any clinically-driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

QCA & IVUS derived parameters

Description

Late Loss, Restenosis Rate, %DS, MLD & Neointimal Volume

Time Frame

12 months

Title

Major Adverse Coronary Events

Description

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).

Time Frame

60 months

Title

Procedural and Technical Success

Description

percentage of patients with angiographic success successful delivery and deployment of the device

Time Frame

Acute

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandre Abizaid, MD

Organizational Affiliation

Instituto Dante Pazzanese de Cardiologia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto Dante Pazzanese de Cardiologia

City

Sao Paulo

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Safety Study of a Bioresorbable Coronary Stent

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