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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01845311




Registration number
NCT01845311
Ethics application status
Date submitted
21/03/2013
Date registered
3/05/2013
Date last updated
29/03/2023

Titles & IDs
Public title
ReZolve2 Clinical Investigation
Scientific title
RESTORE II Trial: Safety & Performance Study of the ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold
Secondary ID [1] 0 0
HCT4000
Universal Trial Number (UTN)
Trial acronym
RESTORE II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Coronary Artery Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: ReZolve2 Treatment Group -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Adverse Cardiac Events (MACE)
Assessment method [1] 0 0
Timepoint [1] 0 0
6 Months
Primary outcome [2] 0 0
Major Adverse Cardiac Events
Assessment method [2] 0 0
Timepoint [2] 0 0
12 Months
Primary outcome [3] 0 0
Late Lumen Loss
Assessment method [3] 0 0
Timepoint [3] 0 0
9 Months
Secondary outcome [1] 0 0
QCA derived parameters
Assessment method [1] 0 0
Late Loss, Restenosis Rate, % Diameter Stenosis \& Minimum Lumen Diameter
Timepoint [1] 0 0
9 Months
Secondary outcome [2] 0 0
Major Adverse Coronary Events
Assessment method [2] 0 0
Major Adverse Coronary Events - Combined events consisting of death, myocardial infarction and Target Lesion Revascularization
Timepoint [2] 0 0
24, 36, 48 & 60 Months
Secondary outcome [3] 0 0
TLR
Assessment method [3] 0 0
Target Lesion Revascularization
Timepoint [3] 0 0
12,24,36,48 & 60 Months
Secondary outcome [4] 0 0
TVR
Assessment method [4] 0 0
Target Vessel Revascularization
Timepoint [4] 0 0
12,24,36,48 & 60 Months
Secondary outcome [5] 0 0
TVF
Assessment method [5] 0 0
Target Vessel Failure
Timepoint [5] 0 0
12, 24, 36, 48 & 60 Month
Secondary outcome [6] 0 0
Acute Procedural Success
Assessment method [6] 0 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.
Timepoint [6] 0 0
Day 0
Secondary outcome [7] 0 0
Acute Technical Success
Assessment method [7] 0 0
The percentage of patients with successful delivery and deployment of the scaffold in the intended lesion without device related complications.
Timepoint [7] 0 0
Day 0
Secondary outcome [8] 0 0
Clinical Procedural Success
Assessment method [8] 0 0
The percentage of patients meeting the Acute Procedural Success criteria with no occurrence of a MACE event through 30 days.
Timepoint [8] 0 0
30 Days

Eligibility
Key inclusion criteria
Primary

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2019
Sample size
Target
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Sao Paulo
Country [2] 0 0
Germany
State/province [2] 0 0
Frankfurt

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
REVA Medical, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Alexandre Abizaid, MD
Address 0 0
Instituto Dante Pazzanese de Cardiologia
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01845311