ReZolve2 Clinical Investigation (RESTORE II)

March 27, 2023 updated by: REVA Medical, Inc.

RESTORE II Trial: Safety & Performance Study of the ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold

The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Sydney, Australia
        • St Vincent's Hospital
  • Brazil
      • Sao Paulo, Brazil
        • Instituto Dante Pazzanese de Cariologia
  • Germany
      • Frankfurt, Germany
        • Cardioangiologisches Centrum Bethanien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Primary 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 ≥ 2.75mm and ≤ 3.3mm
  • Target lesion length must be ≤ 14mm

Primary 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 < 30%
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ReZolve2 Treatment Group
Device: ReZolve2 Scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major Adverse Cardiac Events (MACE)
Time Frame: 6 Months
6 Months
Major Adverse Cardiac Events
Time Frame: 12 Months
12 Months
Late Lumen Loss
Time Frame: 9 Months
9 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QCA derived parameters
Time Frame: 9 Months
Late Loss, Restenosis Rate, % Diameter Stenosis & Minimum Lumen Diameter
9 Months
Major Adverse Coronary Events
Time Frame: 24, 36, 48 & 60 Months
Major Adverse Coronary Events - Combined events consisting of death, myocardial infarction and Target Lesion Revascularization
24, 36, 48 & 60 Months
TLR
Time Frame: 12,24,36,48 & 60 Months
Target Lesion Revascularization
12,24,36,48 & 60 Months
TVR
Time Frame: 12,24,36,48 & 60 Months
Target Vessel Revascularization
12,24,36,48 & 60 Months
TVF
Time Frame: 12, 24, 36, 48 & 60 Month
Target Vessel Failure
12, 24, 36, 48 & 60 Month
Acute Procedural Success
Time Frame: Day 0
The percentage of patients meeting the Acute Technical Success criteria and the procedure results in a residual stenosis of <50 percent with no immediate (in-hospital) MACE.
Day 0
Acute Technical Success
Time Frame: Day 0
The percentage of patients with successful delivery and deployment of the scaffold in the intended lesion without device related complications.
Day 0
Clinical Procedural Success
Time Frame: 30 Days
The percentage of patients meeting the Acute Procedural Success criteria with no occurrence of a MACE event through 30 days.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

REVA Medical, Inc.

Investigators

  • Principal Investigator: Alexandre Abizaid, MD, Instituto Dante Pazzanese de Cardiologia
  • Principal Investigator: David Muller, MD, St Vincent's Hospital, Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCT4000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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