ReZolve2 Clinical Investigation

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Coronary Artery Stenosis

• Registration Number: NCT01845311
• Lead Sponsor: REVA Medical, Inc.

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 available

Study Timeline

• Study First Submitted: 2013-03-21
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-05-03
• Primary Completion: 2014-01
• Study Completion: 2019-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Late Lumen Loss	9 Months
Major Adverse Cardiac Events	12 Months
Major Adverse Cardiac Events (MACE)	6 Months

Secondary Outcome Measures

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

Trial Locations

Locations (3)

St Vincent's Hospital; 🇦🇺 Sydney, Australia

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

Cardioangiologisches Centrum Bethanien; 🇩🇪 Frankfurt, Germany