Coronary Artery DiseaseENHANCENCT02747199
ENdothelial Healing Assessment With Novel Coronary tEchnology
A study testing SYNERGY stent and BVS ABSORB scaffold in people with Coronary Artery Disease, run by University of Malaya.
Trial summary
This is a prospective, non-randomized, single center clinical trial to assess neointimal coverage on the stent or scaffold strut and apposition of SYNERGY™ and ABSORB in minimum of 12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using OCT and CAS Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- SYNERGY stent and BVS ABSORB scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to 12 Apr 2017
- 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
- Subject is 20 years old or older
- Subject or legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
- Subject must have evidence of myocardial ischemia (eg stable or unstable angina, silent ischemia) suitable for elective PCI
- Significant narrowing of at least 70% stenosis of de novo lesion (QCA or visual estimation) in 2 different native coronary arteries.
- Subject is eligible for to undergo OCT and CAS examination at 4 months and 12 months after stent or scaffold implantation.
- Subject is able to take dual anti-platelet therapy up to one year following the index procedure and anticoagulants prior/during the index procedure
Who cannot join
- Subject had an acute myocardial infarction (STEMI or NSTEMI) within 24 hours of the index procedure
- Subject has known left ventricular ejection fraction (LVEF) < 30%
- Subject is receiving hemodialysis
- Target vessel were treated by PCI within 12 months
- Target lesion is located within a saphenous vein graft or an arterial graft
- Target lesion is located in ostium
- Target lesion is located highly tortuous equal to or greater than 60 degrees
- Target lesion with TIMI flow 0 (total occlusion)
About this study
Official title: Comparison Between SYNERGY™ vs. Bioresorbable Vascular Scaffold (BVS) ABSORB Neointimal Formation Assessed by (Optical Coherence Tomography) OCT and Coronary Angioscopy (CAS) Evaluation (The ENHANCE Study - ENdothelial Healing Assessment With Novel Coronary tEchnology)
This is a prospective, non-randomized, single center clinical trial to assess neointimal coverage on the stent or scaffold strut and apposition of SYNERGY™ and ABSORB in minimum of 12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using OCT and CAS
Read the detailed description
All of the subject will received SYNERGY™ stent in one of the blocked coronary artery and ABSORB scaffold strut in the other artery. All subjects must have 2 coronary arteries stenosis of more than 70%.
- Conditions
- Coronary Artery Disease
- Being tested
- SYNERGY stent, BVS ABSORB scaffold
- Keywords
- SYNERGY, Neointimal formation, OCT, coronary angioscopy, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNERGY stentDevice
BVS ABSORB scaffoldDevice
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery implanted with SYNERGY stent | Active comparator | One of the blocked coronary artery of a patient will received SYNERGY stent Receives: Device: SYNERGY stent |
| Coronary artery implanted with ABSORB scaffold | Active comparator | Another blocked coronary artery of the same patient will received ABSORB scaffold Receives: Device: BVS ABSORB scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apposition and neointimal coverage on the stent and scaffold strut
Neointimal coverage on the stent and scaffold strut and their apposition using OCT and CAS at 4 month after the stent implantation.
Measured: 4 months
Secondary outcomes (1)
Apposition and neointimal coverage on the stent and scaffold strut
Neointimal coverage on the stent or scaffold and their apposition using OCT and CAS at 12 month after stent implantation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completion12 Apr 2017
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.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation, Kurume University
- Responsible party
- Principal investigator, Wan Azman Wan Ahmad, University of Malaya
- Investigators
- Wan Azman Wan Ahmad, Principal investigator, University Malaya Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747199
- Sponsor's protocol ID
- ISROTH10249
- Acronym
- ENHANCE
- Status last verified
- May 2017
- First submitted
- 19 Apr 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between SYNERGY™ vs. Bioresorbable Vascular Scaffold (BVS) ABSORB Neointimal Formation Assessed by (Optical Coherence Tomography) OCT and Coronary Angioscopy (CAS) Evaluation (The ENHANCE Study - ENdothelial Healing Assessment With Novel Coronary tEchnology)
- ClinicalTrials.gov ID
- NCT02747199
- Acronym / sponsor ID
- ENHANCE / ISROTH10249
- Conditions
- Coronary Artery Disease
- Keywords
- SYNERGY, Neointimal formation, OCT, coronary angioscopy, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation, Kurume University
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 21 Apr 2016 (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.
This is a prospective, non-randomized, single center clinical trial to assess neointimal coverage on the stent or scaffold strut and apposition of SYNERGY™ and ABSORB in minimum of 12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using OCT and CAS
Detailed description
All of the subject will received SYNERGY™ stent in one of the blocked coronary artery and ABSORB scaffold strut in the other artery. All subjects must have 2 coronary arteries stenosis of more than 70%.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary artery implanted with SYNERGY stent | Active comparator | Device: SYNERGY stentOne of the blocked coronary artery of a patient will received SYNERGY stent |
| Coronary artery implanted with ABSORB scaffold | Active comparator | Device: BVS ABSORB scaffoldAnother blocked coronary artery of the same patient will received ABSORB scaffold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is 20 years old or older
- Subject or legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
- Subject must have evidence of myocardial ischemia (eg stable or unstable angina, silent ischemia) suitable for elective PCI
- Significant narrowing of at least 70% stenosis of de novo lesion (QCA or visual estimation) in 2 different native coronary arteries.
- Subject is eligible for to undergo OCT and CAS examination at 4 months and 12 months after stent or scaffold implantation.
Key exclusion criteria (8 listed)
- Subject had an acute myocardial infarction (STEMI or NSTEMI) within 24 hours of the index procedure
- Subject has known left ventricular ejection fraction (LVEF) < 30%
- Subject is receiving hemodialysis
- Target vessel were treated by PCI within 12 months
- Target lesion is located within a saphenous vein graft or an arterial 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 |
|---|---|---|
| SYNERGY stent | Device | Coronary artery implanted with SYNERGY stent |
| BVS ABSORB scaffold | Device | Coronary artery implanted with ABSORB scaffold |
Primary outcome
Apposition and neointimal coverage on the stent and scaffold strut
Time frame: 4 months
Neointimal coverage on the stent and scaffold strut and their apposition using OCT and CAS at 4 month after the stent implantation.
1 secondary outcome
Apposition and neointimal coverage on the stent and scaffold strut
Time frame: 12 months
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 4 May 2017.
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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.
Wan Azman Wan Ahmad principal investigator
University Malaya Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing SYNERGY stent and BVS ABSORB scaffold in people with Coronary Artery Disease, run by University of Malaya.
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 6 inclusion and 8 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Apposition and neointimal coverage on the stent and scaffold strut (time frame: 4 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 4 May 2017.