Coronary Artery DiseaseRESTORE IINCT01845311
ReZolve2 Clinical Investigation
A study testing ReZolve2 Scaffold in people with Coronary Artery Disease and Coronary Artery Stenosis, run by REVA Medical, Inc. at 3 sites in 3 countries.
Trial summary
The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Stenosis
- What is being tested?
- ReZolve2 Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2013to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: RESTORE II Trial: Safety & Performance Study of the ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold
The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis
- Being tested
- ReZolve2 Scaffold
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReZolve2 ScaffoldDevice
| Study group | Role | What they receive |
|---|---|---|
| ReZolve2 Treatment Group | Experimental | Not described Receives: Device: ReZolve2 Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE)
Measured: 6 Months
Major Adverse Cardiac Events
Measured: 12 Months
Late Lumen Loss
Measured: 9 Months
Secondary outcomes (8)
QCA derived parameters
Late Loss, Restenosis Rate, % Diameter Stenosis \& Minimum Lumen Diameter
Measured: 9 Months
Major Adverse Coronary Events
Major Adverse Coronary Events - Combined events consisting of death, myocardial infarction and Target Lesion Revascularization
Measured: 24, 36, 48 & 60 Months
TLR
Target Lesion Revascularization
Measured: 12,24,36,48 & 60 Months
TVR
Target Vessel Revascularization
Measured: 12,24,36,48 & 60 Months
TVF
Target Vessel Failure
Measured: 12, 24, 36, 48 & 60 Month
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.
Measured: Day 0
Acute Technical Success
The percentage of patients with successful delivery and deployment of the scaffold in the intended lesion without device related complications.
Measured: Day 0
Clinical Procedural Success
The percentage of patients meeting the Acute Procedural Success criteria with no occurrence of a MACE event through 30 days.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- REVA Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre Abizaid, MD, Principal investigator, Instituto Dante Pazzanese de CardiologiaDavid Muller, MD, Principal investigator, St Vincent's Hospital, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845311
- Sponsor's protocol ID
- HCT4000
- Acronym
- RESTORE II
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2013
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTORE II Trial: Safety & Performance Study of the ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold
- ClinicalTrials.gov ID
- NCT01845311
- Acronym / sponsor ID
- RESTORE II / HCT4000
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- REVA Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReZolve2 Treatment Group | Experimental | Device: ReZolve2 Scaffold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReZolve2 Scaffold | Device | ReZolve2 Treatment Group |
Primary outcome
Major Adverse Cardiac Events (MACE)
Time frame: 6 Months
Major Adverse Cardiac Events
Time frame: 12 Months
Late Lumen Loss
Time frame: 9 Months
8 secondary outcomes
QCA derived parameters
Time frame: 9 Months
Major Adverse Coronary Events
Time frame: 24, 36, 48 & 60 Months
TLR
Time frame: 12,24,36,48 & 60 Months
TVR
Time frame: 12,24,36,48 & 60 Months
TVF
Time frame: 12, 24, 36, 48 & 60 Month
Acute Procedural Success
Time frame: Day 0
Acute Technical Success
Time frame: Day 0
Clinical Procedural Success
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Abizaid, MD principal investigator
Instituto Dante Pazzanese de Cardiologia
David Muller, MD principal investigator
St Vincent's Hospital, Sydney
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReZolve2 Scaffold in people with Coronary Artery Disease and Coronary Artery Stenosis, run by REVA Medical, Inc. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Brazil, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (MACE) (time frame: 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.