Coronary Artery DiseaseMeRes-1ExtendNCT02663323
Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System
A study testing MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in people with Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd. at 4 sites in 4 countries.
Trial summary
MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native coronary artery lesions. 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?
- MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 2 Feb 2016to 5 Jul 2020
- 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
- General Inclusion Criteria:
- Male or female subjects ≥ 18 years of age
- Subject is able to sign written Informed Consent Form (ICF)
- Subjects with symptomatic myocardial ischemia, chronic stable angina
- The patient has planned intervention of a single de novo lesion in native epicardial vessel
- Subject who is an acceptable candidate for Coronary Artery Bypass Grafting (CABG)
Show all 12Show fewer
- Subject is not participating in any other clinical investigation/study and agrees not to participate in any other clinical investigation/study for a period of 3 years following the index procedure.
- Subject must agree to undergo all clinical investigation plan-required follow-up visits, angiograms and OCT as per protocol.
- Angiographic Inclusion Criteria:
- Subject with maximum two treatable de novo lesions located maximum one per native epicardial vessel located in major artery or branch, with reference vessel diameter between 2.75, 3.00 and 3.5 mm by on line QCA.
- Target lesion length ≤ 20 mm.
- Subjects with Lesion(s), with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
Who cannot join
- General Exclusion Criteria:
- Subjects unable to provide written informed consent.
- Pregnant or nursing mother and those who plan pregnancy during the clinical investigation (female patients must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraceptive must be used during participation in this clinical investigation).
- Subjects with known allergy to Poly-L-Lactide (PLLA), Poly-D,L-Lactide (PDLLA), Sirolimus (Rapamycin) or its any analog or derivative, clopidogrel, ticlopidine, prasugrel, contrast media, platinum, ticagrelor and any drug in dual antiplatelet therapy including aspirin, both heparin and bivalirudin.
- Subject diagnosed with Acute Myocardial Infarction (AMI) within 7 days preceding the index procedure, as indicated by elevated levels of cardiac enzymes and/or ST segment changes in Electro Cardio Gram (ECG).
- Subject with history of previous revascularization procedures including CABG and Percutaneous Coronary Intervention (PCI).
Show all 33Show fewer
- Subject with vascular aneurysms, cardiac arrhythmias, congestive cardiac failure having LVEF < 30%, cardiac tamponade.
- Recipient of an organ in an organ transplant procedure or is on a waiting list for any organ transplant.
- Subjects receiving immunosuppression therapy or having known immunosuppressive or autoimmune disease.
- Subjects with history of stroke, Cerebro Vascular Accident (CVA) or Transient Ischemic neurological Attack (TIA). Patients with renal insufficiency where creatinine levels are more than 1.3 mg/dl, known aplastic anaemia, chronic liver disease, platelet count <100,000 cells/mm3, a WBC of < 3,000 cells/mm3.
- Subjects planned for elective surgery within the first 12 months after the procedure that will require discontinuing dual antiplatelet therapy
- Subject has a history of bleeding diathesis or coagulatory disease, refuses blood transfusion, significant gastrointestinal or urinary bleed within the past 12 months.
- Subject having extensive peripheral vascular disease that precludes safe 6F sheath insertion.
- Subject having a history of paradoxical exercise induced vasoconstriction that is consistent with myocardial bridging in the coronary anatomy.
- Subjects participating in another clinical investigation.
- Subjects with short life expectancy such as cancer, Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS), or other co-morbid conditions that would limit compliance with the follow-up schedule of the study.
- Angiographic Exclusion Criteria:
- Subjects who are non-candidates for PCI.
- Any of the target lesions meets any of the following criteria:
- Aorto-ostial location (within 3 mm)
- Lesion located in left main coronary artery
- Lesion located within 2 mm of origin of the LAD or LCx
- Lesion that involves a bifurcation with a side branch ≥ 2mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring intervention
- Total occlusion (TIMI Flow 0), prior to wire crossing
- Extreme tortuosity proximal to or within the lesion
- Lesions having heavy calcification
- Extreme angulation (≥ 90 %) proximal to or within the lesion
- Evidence of previous revascularization:
- Previous PCI with or without restenosis from previous intervention
- Arterial or venous graft with or without lesion located within the graft or distal to a diseased arterial or saphenous vein graft
- The target vessel contains visible thrombus.
- Another (clinically significant or potentially significant) lesion left untreated within target vessels (including side branch) or another significant vessel.
- Subject requiring or potentially requiring interventional procedures other than pre-dilatation and study device implantation and post dilatation.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Brazil1 site
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-909
About this study
Official title: MeRes-1 Extend: A Prospective, Multinational, Multicenter, Single Arm, Open Label, Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the Treatment of De-novo Native Coronary Artery Lesions
MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native coronary artery lesions. 64 subjects will be enrolled from the 8 centers located in Asia Pacific, Europe, Brazil and South Africa. Primary outcome of study will be Proportion of population reporting Major Adverse Cardiac Events at 6 months from the day of index Procedure.
- Conditions
- Coronary Artery Disease
- Being tested
- MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System
- Keywords
- Coronary Artery Disease, MeRes-1 Extend, MeRes100, Sirolimus Eluting Bioresorbable Vascular Scaffold System
- 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.
MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold SystemDevice
MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the treatment of de-novo coronary artery lesions.
| Study group | Role | What they receive |
|---|---|---|
| MeRes100 - BRS | Experimental | MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System Receives: Device: MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Clinical Endpoint: Proportion of population reporting with Major Adverse Cardiac Event at 6 months from the day of index procedure.
Measured: 6 Month
Primary Safety Endpoint: Proportion of population reporting with Ischemia Driven Major Adverse Cardiac Event (ID MACE) reporting at 6 months (180 days) from the day of index procedure
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start2 Feb 2016
- Primary completion5 Oct 2017
- Study completion5 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Single intervention with MeRes100 Device
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Alexandre Abizaid, Principal investigator, Dante Pazzanese Hospital, Sao Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663323
- Sponsor's protocol ID
- MER/EX
- Acronym
- MeRes-1Extend
- Status last verified
- Aug 2018
- First submitted
- 7 Dec 2015
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Abizaid A, Kedev S, Ali RBM, Santoso T, Cequier A, van Geuns RVG, Chevalier B, Hellig F, Costa R, Onuma Y, Costa JR Jr, Serruys P, Bangalore S. Imaging and 2-year clinical outcomes of thin strut sirolimus-eluting bioresorbable vascular scaffold: The MeRes-1 extend trial. Catheter Cardiovasc Interv. 2021 Nov 15;98(6):1102-1110. doi: 10.1002/ccd.29396. Epub 2020 Dec 2.
PubMed 33269506
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MeRes-1 Extend: A Prospective, Multinational, Multicenter, Single Arm, Open Label, Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the Treatment of De-novo Native Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT02663323
- Acronym / sponsor ID
- MeRes-1Extend / MER/EX
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, MeRes-1 Extend, MeRes100, Sirolimus Eluting Bioresorbable Vascular Scaffold System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 5 Oct 2017 (actual)
- Study completion
- 5 Jul 2020 (estimated)
- First posted
- 26 Jan 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.
MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native coronary artery lesions. 64 subjects will be enrolled from the 8 centers located in Asia Pacific, Europe, Brazil and South Africa. Primary outcome of study will be Proportion of population reporting Major Adverse Cardiac Events at 6 months from the day of index Procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single intervention with MeRes100 Device
| Arm | Type | Receives |
|---|---|---|
| MeRes100 - BRS | Experimental | Device: MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold SystemMeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects ≥ 18 years of age
- Subject is able to sign written Informed Consent Form (ICF)
- Subjects with symptomatic myocardial ischemia, chronic stable angina
- The patient has planned intervention of a single de novo lesion in native epicardial vessel
- Subject who is an acceptable candidate for Coronary Artery Bypass Grafting (CABG)
Key exclusion criteria (33 listed)
- Subjects unable to provide written informed consent.
- Pregnant or nursing mother and those who plan pregnancy during the clinical investigation (female patients must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraceptive must be used during participation in this clinical investigation).
- Subjects with known allergy to Poly-L-Lactide (PLLA), Poly-D,L-Lactide (PDLLA), Sirolimus (Rapamycin) or its any analog or derivative, clopidogrel, ticlopidine, prasugrel, contrast media, platinum, ticagrelor and any drug in dual antiplatelet therapy including aspirin, both heparin and bivalirudin.
- Subject diagnosed with Acute Myocardial Infarction (AMI) within 7 days preceding the index procedure, as indicated by elevated levels of cardiac enzymes and/or ST segment changes in Electro Cardio Gram (ECG).
- Subject with history of previous revascularization procedures including CABG and Percutaneous Coronary Intervention (PCI).
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 |
|---|---|---|
| MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold SystemMeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the treatment of de-novo coronary artery lesions. | Device | MeRes100 - BRS |
Primary outcome
Primary Clinical Endpoint: Proportion of population reporting with Major Adverse Cardiac Event at 6 months from the day of index procedure.
Time frame: 6 Month
Primary Safety Endpoint: Proportion of population reporting with Ischemia Driven Major Adverse Cardiac Event (ID MACE) reporting at 6 months (180 days) from the day of index procedure
Time frame: 6 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Derived from this study: PubMed 33269506Abizaid A, Kedev S, Ali RBM, Santoso T, Cequier A, van Geuns RVG, Chevalier B, Hellig F, Costa R, Onuma Y, Costa JR Jr, Serruys P, Bangalore S. Imaging and 2-year clinical outcomes of thin strut sirolimus-eluting bioresorbable vascular scaffold: The MeRes-1 extend trial. Catheter Cardiovasc Interv. 2021 Nov 15;98(6):1102-1110. doi: 10.1002/ccd.29396. Epub 2020 Dec 2.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Dr. Alexandre Abizaid principal investigator
Dante Pazzanese Hospital, Sao Paulo, Brazil
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in people with Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd. at 4 sites in 4 countries.
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 12 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil, Indonesia, Malaysia, North Macedonia. 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?
Results are not available in the source record.
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?
Primary Clinical Endpoint: Proportion of population reporting with Major Adverse Cardiac Event at 6 months from the day of index procedure. (time frame: 6 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02663323, which also lists 1 linked publication.
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 17 Aug 2018.