Myocardial IschemiaRESTORENCT01262703
Safety Study of a Bioresorbable Coronary Stent
A study testing ReZolve Stent in people with Myocardial Ischemia and Coronary Artery Stenosis, run by REVA Medical, Inc. at 1 site in Brazil.
Trial summary
To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease
- What is being tested?
- ReZolve Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2011to Dec 2018
- 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
Who may be able to join
- Evidence of myocardial ischemia or a positive functional study.
- Normal CK-MB.
- Target lesion must be located in a native coronary artery where target vessel diameter is ≥ 2.9 mm and ≤ 3.3 mm and target lesion length is ≤ 12 mm, both assessed by on-line QCA and IVUS
- Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 2.
- Staged procedures are allowed in non-target vessels >24 hours before or > 30 days after REVA stent implantation
Who cannot join
- A myocardial infarction (CK-MB or Troponin > 3 times normal) within 72 hours of the procedure, has signs or symptoms of an ongoing myocardial infarction or has any visible thrombus
- Unprotected left main coronary disease with >50% stenosis
- The target vessel is totally occluded (TIMI Flow 0 to 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 segment supplied by distal graft
- Target lesion has possible or definite thrombus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent
To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.
Read the detailed description
Today, coronary artery disease is often treated by placing a metal stent inside the vessel that serves as a permanent scaffold. However, it is hypothesized that the stent is no longer needed once the artery has healed. This study will evaluate the safety of a bioresorbable (non-permanent) stent for the treatment of coronary artery disease. The stent is designed to restore blood flow to the artery which allows the artery to remodel (heal), and then resorb from the body. The stent supports the vessel during the critical 90-day healing process, and then gradually resorbs and is cleared from the body.
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Cardiovascular Disease
- Being tested
- ReZolve Stent
- Medical subject headings
- Myocardial Ischemia, Coronary Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReZolve StentDevice
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent
| Study group | Role | What they receive |
|---|---|---|
| REVA Medical ReZolve Stent | Experimental | ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent Receives: Device: ReZolve Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemia-driven Target Lesion Revascularization (TLR)
Defined as any clinically-driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
Measured: 6 months
Secondary outcomes (3)
QCA & IVUS derived parameters
Late Loss, Restenosis Rate, %DS, MLD \& Neointimal Volume
Measured: 12 months
Major Adverse Coronary Events
Major Adverse Cardiac Events - Combined events consisting of death, Myocardial Infarction (Q-Wave, Non Q-wave: CPK > 2xULN + MB>ULN) (MI), and target vessel revascularization (TVR).
Measured: 60 months
Procedural and Technical Success
percentage of patients with angiographic success successful delivery and deployment of the device
Measured: Acute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 2011
- Primary completionOct 2013
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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
- 49 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 Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262703
- Sponsor's protocol ID
- HCT1000
- Acronym
- RESTORE
- Status last verified
- Mar 2023
- First submitted
- 16 Dec 2010
- 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
- Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent
- ClinicalTrials.gov ID
- NCT01262703
- Acronym / sponsor ID
- RESTORE / HCT1000
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- REVA Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 17 Dec 2010 (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.
To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.
Detailed description
Today, coronary artery disease is often treated by placing a metal stent inside the vessel that serves as a permanent scaffold. However, it is hypothesized that the stent is no longer needed once the artery has healed. This study will evaluate the safety of a bioresorbable (non-permanent) stent for the treatment of coronary artery disease. The stent is designed to restore blood flow to the artery which allows the artery to remodel (heal), and then resorb from the body. The stent supports the vessel during the critical 90-day healing process, and then gradually resorbs and is cleared from the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REVA Medical ReZolve Stent | Experimental | Device: ReZolve StentReZolve Sirolimus-Eluting Bioresorbable Coronary Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Evidence of myocardial ischemia or a positive functional study.
- Normal CK-MB.
- Target lesion must be located in a native coronary artery where target vessel diameter is ≥ 2.9 mm and ≤ 3.3 mm and target lesion length is ≤ 12 mm, both assessed by on-line QCA and IVUS
- Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 2.
- Staged procedures are allowed in non-target vessels >24 hours before or > 30 days after REVA stent implantation
Key exclusion criteria (6 listed)
- A myocardial infarction (CK-MB or Troponin > 3 times normal) within 72 hours of the procedure, has signs or symptoms of an ongoing myocardial infarction or has any visible thrombus
- Unprotected left main coronary disease with >50% stenosis
- The target vessel is totally occluded (TIMI Flow 0 to 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 segment supplied by distal graft
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 |
|---|---|---|
| ReZolve StentReZolve Sirolimus-Eluting Bioresorbable Coronary Stent | Device | REVA Medical ReZolve Stent |
Primary outcome
Ischemia-driven Target Lesion Revascularization (TLR)
Time frame: 6 months
Defined as any clinically-driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
3 secondary outcomes
QCA & IVUS derived parameters
Time frame: 12 months
Major Adverse Coronary Events
Time frame: 60 months
Procedural and Technical Success
Time frame: Acute
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReZolve Stent in people with Myocardial Ischemia and Coronary Artery Stenosis, run by REVA Medical, Inc. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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 1 site in Brazil. 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?
Ischemia-driven Target Lesion Revascularization (TLR) (time frame: 6 months). 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.