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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)
Timepoint [1] 0 0
6 Months
Primary outcome [2] 0 0
Major Adverse Cardiac Events
Timepoint [2] 0 0
12 Months
Primary outcome [3] 0 0
Late Lumen Loss
Timepoint [3] 0 0
9 Months
Secondary outcome [1] 0 0
QCA derived parameters
Timepoint [1] 0 0
9 Months
Secondary outcome [2] 0 0
Major Adverse Coronary Events
Timepoint [2] 0 0
24, 36, 48 & 60 Months
Secondary outcome [3] 0 0
TLR
Timepoint [3] 0 0
12,24,36,48 & 60 Months
Secondary outcome [4] 0 0
TVR
Timepoint [4] 0 0
12,24,36,48 & 60 Months
Secondary outcome [5] 0 0
TVF
Timepoint [5] 0 0
12, 24, 36, 48 & 60 Month
Secondary outcome [6] 0 0
Acute Procedural Success
Timepoint [6] 0 0
Day 0
Secondary outcome [7] 0 0
Acute Technical Success
Timepoint [7] 0 0
Day 0
Secondary outcome [8] 0 0
Clinical Procedural Success
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.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.
Trial website
https://clinicaltrials.gov/study/NCT01845311
Trial related presentations / publications
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01845311