ReZolve2 Clinical Investigation

Coronary Artery Disease Clinical Trial

— RESTORE II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845311
• Other study ID #: HCT4000
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: January 2019

Study information

• Verified date: March 2023
• Source: REVA Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 2019
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Device:
• ReZolve2 Scaffold

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Sydney
Brazil	Instituto Dante Pazzanese de Cariologia	Sao Paulo
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
REVA Medical, Inc.

Countries where clinical trial is conducted

Australia,  Brazil,  Germany, 

Outcome

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