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ReZolve2 Clinical Investigation (RESTORE II)

Primary Purpose

Coronary Artery Disease, Coronary Artery Stenosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ReZolve2 Scaffold
Sponsored by
REVA Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

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

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

Sites / Locations

  • St Vincent's Hospital
  • Instituto Dante Pazzanese de Cariologia
  • Cardioangiologisches Centrum Bethanien

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ReZolve2 Treatment Group

Arm Description

Outcomes

Primary Outcome Measures

Major Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events
Late Lumen Loss

Secondary Outcome Measures

QCA derived parameters
Late Loss, Restenosis Rate, % Diameter Stenosis & Minimum Lumen Diameter
Major Adverse Coronary Events
Major Adverse Coronary Events - Combined events consisting of death, myocardial infarction and Target Lesion Revascularization
TLR
Target Lesion Revascularization
TVR
Target Vessel Revascularization
TVF
Target Vessel Failure
Acute Procedural Success
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.
Acute Technical Success
The percentage of patients with successful delivery and deployment of the scaffold in the intended lesion without device related complications.
Clinical Procedural Success
The percentage of patients meeting the Acute Procedural Success criteria with no occurrence of a MACE event through 30 days.

Full Information

First Posted
March 21, 2013
Last Updated
March 27, 2023
Sponsor
REVA Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01845311
Brief Title
ReZolve2 Clinical Investigation
Acronym
RESTORE II
Official Title
RESTORE II Trial: Safety & Performance Study of the ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2019 (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
The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ReZolve2 Treatment Group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ReZolve2 Scaffold
Primary Outcome Measure Information:
Title
Major Adverse Cardiac Events (MACE)
Time Frame
6 Months
Title
Major Adverse Cardiac Events
Time Frame
12 Months
Title
Late Lumen Loss
Time Frame
9 Months
Secondary Outcome Measure Information:
Title
QCA derived parameters
Description
Late Loss, Restenosis Rate, % Diameter Stenosis & Minimum Lumen Diameter
Time Frame
9 Months
Title
Major Adverse Coronary Events
Description
Major Adverse Coronary Events - Combined events consisting of death, myocardial infarction and Target Lesion Revascularization
Time Frame
24, 36, 48 & 60 Months
Title
TLR
Description
Target Lesion Revascularization
Time Frame
12,24,36,48 & 60 Months
Title
TVR
Description
Target Vessel Revascularization
Time Frame
12,24,36,48 & 60 Months
Title
TVF
Description
Target Vessel Failure
Time Frame
12, 24, 36, 48 & 60 Month
Title
Acute Procedural Success
Description
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.
Time Frame
Day 0
Title
Acute Technical Success
Description
The percentage of patients with successful delivery and deployment of the scaffold in the intended lesion without device related complications.
Time Frame
Day 0
Title
Clinical Procedural Success
Description
The percentage of patients meeting the Acute Procedural Success criteria with no occurrence of a MACE event through 30 days.
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
First Name & Middle Initial & Last Name & Degree
David Muller, MD
Organizational Affiliation
St Vincent's Hospital, Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Vincent's Hospital
City
Sydney
Country
Australia
Facility Name
Instituto Dante Pazzanese de Cariologia
City
Sao Paulo
Country
Brazil
Facility Name
Cardioangiologisches Centrum Bethanien
City
Frankfurt
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

ReZolve2 Clinical Investigation

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