ReZolve2 Clinical Investigation | NCT01845311

Studies
ReZolve2 Clinical Investigation

NCT01845311

Sponsor

REVA Medical, Inc.

Status

Completed

Last Update Posted

Mar 29, 2023Actual

Enrollment

89Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease
Coronary Artery Stenosis

Interventions

ReZolve2 Scaffold

Countries

Australia
Brazil
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2019Actual

First Submitted Date

Mar 21, 2013

First Submission Date that Met QC Criteria

Apr 29, 2013

First Posted Date

May 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2023

Last Update Posted Date

Mar 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Label	Type	Description	Intervention Names
ReZolve2 Treatment Group	Experimental		Device: ReZolve2 Scaffold

Name	Type	Description	Arm Group Labels	Other Names
ReZolve2 Scaffold	Device		ReZolve2 Treatment Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
QCA derived parameters	Late Loss, Restenosis Rate, % Diameter Stenosis & Minimum Lumen Diameter	9 Months
Major Adverse Coronary Events	Major Adverse Coronary Events - Combined events consisting of death, myocardial infarction and Target Lesion Revascularization

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandre Abizaid, MD	Instituto Dante Pazzanese de Cardiologia	Principal Investigator
David Muller, MD	St Vincent's Hospital, Sydney	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Vincent's Hospital		Sydney			Australia
Instituto Dante Pazzanese de Cariologia

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D023921	Coronary Stenosis

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided