Coronary Artery DiseaseMeReS100-ChinaNCT03454724
Study of MeRes100 in the Treatment of Patient With Coronary Artery Disease.
A study testing MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System and Xience EES Everolimus Eluting Coronary Stent System in people with Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd..
Trial summary
This is a Multi Center Randomized Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in treatment of approximately 484 subjects with Coronary Artery Disease in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System and Xience EES Everolimus Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Dec 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General inclusion criteria:
- Age ≥ 18 and ≤75years old, man or non-pregnant or non-lactating woman.
- Subjects with asymptomatic ischemic evidence, stable or unstable angina, or old myocardial infarction >7 days, suitable for selective PCI. Subjects without contraindications of coronary artery bypass grafting.
- Subjects be able to understand the purpose of this study, volunteer to participate and sign informed consent, willing to accept invasive imaging follow-up.
- Angiographic inclusion criteria:
- One de novo target lesion or up-to two de novo target lesions in different epicardial vessels: Different epicardial vessels are defined as left anterior descending artery (LAD) and its branches, left circumflex artery (LCX) arteries and its branches, and right coronary arteries (RCA) and its branches. Thus, for example, the subject must not have two target lesions required to be treated at the LAD and its branches at the same time.
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- Target lesion diameter stenosis ≥ 70% (or ≥ 50% simultaneously shall have clinical evidence of myocardial ischemia), and TIMI flow grade ≥1.
- Target lesion length ≤ 24mm (estimated visually); reference vessel diameter between ≥ 2.75 mm to ≤ 4.00 mm.
- Each target lesion can be fully covered by one scaffold.
Who cannot join
- General exclusion criteria:
- Any non-target lesion in coronary artery needs to be treated simultaneously or selectively (anticipation within 1 year), non-target lesion defined as any lesion that does not fulfill the inclusion/exclusion criteria.
- Any newly onset acute myocardial infarction within 1 week (< 7days) or, myocardial enzyme has not return to normal level (clinically non-significant) after myocardial infarction.
- Subject has undergone prior PCI within the target vessel during the last 12months or plans to receive another PCI within 6months or subject with history of CABG.
- Subjects with severe heart failure, such as ≥ grade III NYHA or left ventricular ejection fraction <30% (accessed by ECHO/ultrasound or left ventricular angiography).
- Blood tests shows the platelet count is less than 100 × 109 / L, or more than 700 ×109 / L, the white blood cells count is less than 3 × 109 / L.
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- Pre-procedure severe liver or kidney functional damaged: serum creatinine> 1.5mg
- / dl (132.6μmol / L) or subject is receiving hemodialysis, ALT or AST were three times greater than the upper limit of normal.
- Subjects with bleeding tendency, active gastrointestinal ulcers, history of cerebral hemorrhage or history of subarachnoid hemorrhage, history within six months of ischemic stroke, contraindications of anti-platelet agents and anticoagulants treatment, and subjects cannot receive anti-thrombolytic therapy.
- Hypersensitive or allergic to antiplatelet drugs(such as aspirin and clopidogrel), anticoagulant drugs(such as heparin), contrast media, and scaffold components(such as PLLA，PDLLA, sirolimus, everolimus, iridium and platinum).
- The subject's life expectancy is less than 12 months.
- Subjects who anticipated in other drug or medical device clinical trial but haven't finished the primary endpoint evaluation visit.
- The investigators judged that subjects were poorly compliance and unable to complete the study as required.
- Subjects have accepted substantial organ transplant or ready to undergo organ transplant.
- Subjects have unstable arrhythmia, such as high-risk ventricular premature beats, and ventricular tachycardia.
- Subjects are receiving or planning to receive chemotherapy.
- Subjects have received or planning to receive radiotherapy.
- Subjects with immunosuppressive or autoimmune diseases, are receiving or planning to receive immunosuppressive therapy.
- Patients suffering from HIV, HBV or HCV infections
- Subjects are planning to receive or are receiving long-term anticoagulation therapy, such as heparin, warfarin and similar agents.
- Subjects are planning to accept selective surgery within 12 months, need to discontinue aspirin or clopidogrel (DAPT therapy).
- Subjects with diffuse peripheral vascular disease, cannot use 6F catheter.
- Angiographic exclusion criteria:
- Subjects with coronary artery triple vessel lesion in LAD, LCX or RCA, all need to be treated.
- Target lesion locates in left main.
- Target lesion locates in the aorto-ostial of RCA (within 3 mm of the origin of the RCA).
- Target lesion locates within 3 mm of the origin of the LM, LAD and LCX.
- Target lesion involving a bifurcation with a:
- Side branch ≥2.0 mm in diameter, or
- Side branch with diameter stenosis ≥ 50%, or
- Side branch requiring protection guide wire, or
- Side branch requiring pre-dilatation.
- Anatomy proximal to or within the lesion that may impair delivery of the
- MeRes100TM or Xience EES, including:
- Extreme angulation (≥ 90°) proximal to or within the target lesion
- Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion
- Moderate or heavy calcification proximal to or within the target lesion
- Target lesion involves a myocardial bridge.
- Target vessel contains thrombus as indicated in the angiographic images or IVUS.
- Target vessel has been previously treated with a stent at any time prior to the index procedure such that the MeRes100TM or XIENCE stent would need to cross the stent to reach the target lesion..
- Target vessel has been previously treated with a stent and the target lesion is within 5 mm proximal to a previously treated lesion.
- Chronic complete occlusive lesion (preoperative TIMI grade 0 flow).
- Target lesion which prevents complete balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
- Residual %DS is < 40% (per visual estimation), ( ≤ 20% is strongly recommended).
- TIMI Grade-3 flow (per visual estimation).
- No angiographic complications (e.g., no-reflow, distal embolization, side branch closure).
- No dissections NHLBI grade D-F.
- No chest pain lasting > 5 minutes.
- No ST depression or elevation lasting > 5 minutes.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi Center Randomized Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in Treatment of Coronary Artery Disease Patients: MeRes - China.
This is a Multi Center Randomized Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in treatment of approximately 484 subjects with Coronary Artery Disease in China. Eligible subjects shall have up to two de novo lesions in different epicardial vessels (One lesion in each coronary artery or it's major branch),Target lesion shall have visually estimated diameter stenosis ≥ 70% (or ≥ 50% and has clinical evidence of myocardial ischemia), lesion length ≤ 24mm, reference vascular diameter visually ≥ 2.75mm and ≤ 4.0mm. And subjects must meet all the study inclusion / exclusion criteria before enrolment in the study.All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post procedure.
Read the detailed description
This is a Multi Center Randomized (MeRes:XIENCE=1:1) Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in treatment of approximately 484 subjects with Coronary Artery Disease in China. The post marketed XIENCE Everolimus Eluting Coronary Stent System will serve as the control device, to evaluate the safety and efficacy of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in coronary artery disease, and to support the product registration approval of the China Food and Drug Administration (CFDA).
Eligible subjects shall have up to two de novo lesions in different epicardial vessels ( One lesion in each coronary artery or it's major branch),Target lesion shall have visually estimated diameter stenosis ≥ 70% (or ≥ 50% and has clinical evidence of myocardial ischemia), lesion length ≤ 24mm, reference vascular diameter visually ≥ 2.75mm and ≤ 4.0mm. And subjects must meet all the study inclusion / exclusion criteria before enrolment in the study.
All the subjects shall accept angiography follow up at 12 months post procedure.
OCT subgroup ((N=80, 40 from test group and 40 from control group) shall accept follow up of OCT at immediately and 12 months post procedure. In segment late lumen loss at 12 months post procedure is the primary endpoint, and the percentage of stent strut neointimal coverage assessed with OCT at 12 months post procedure is the key secondary endpoint.
- Conditions
- Coronary Artery Disease
- Being tested
- MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System, Xience EES Everolimus Eluting Coronary Stent System
- Keywords
- 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 used in the treatment of patients with coronary artery disease along with standard percutaneous angioplasty procedure.
Xience EES Everolimus Eluting Coronary Stent SystemDevice
Xience EES Everolimus Eluting Coronary Stent System indicated for the treatment of coronary artery disease along with standard percutaneous angioplasty procedure.
| Study group | Role | What they receive |
|---|---|---|
| MeRes100 BRS | Experimental | MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System indicated for the treatment of coronary artery disease along with standard percutaneous angioplasty procedure. Receives: Device: MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System; Device: Xience EES Everolimus Eluting Coronary Stent System |
| Xience EES | Active comparator | Xience EES is a Everolimus Eluting Coronary Stent System indicated for the treatment of coronary artery disease along with standard percutaneous angioplasty procedure. Receives: Device: MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System; Device: Xience EES Everolimus Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment Late Lumen Loss
Angiographic analysis for measuring Late Lumen Loss in both the treatment group
Measured: 12 Months
Secondary outcomes (1)
The percentage of stent strut neointimal coverage assessed with OCT
OCT analysis will be done to identify percentage of Neointimal coverage
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 posted6 Mar 2018
- Study start1 Jan 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2024 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 Randomization of Study Device and Control
- Masking
- None (open label)
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gao Runlin, MD, Principal investigator, Fuwai Hospital CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454724
- Sponsor's protocol ID
- MeRes-201706
- Acronym
- MeReS100-China
- Status last verified
- Aug 2019
- First submitted
- 15 Jan 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center Randomized Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in Treatment of Coronary Artery Disease Patients: MeRes - China.
- ClinicalTrials.gov ID
- NCT03454724
- Acronym / sponsor ID
- MeReS100-China / MeRes-201706
- Conditions
- Coronary Artery Disease
- Keywords
- BioResorbable Vascular Scaffold System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Meril Life Sciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Mar 2018 (actual)
- 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 Multi Center Randomized Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in treatment of approximately 484 subjects with Coronary Artery Disease in China. Eligible subjects shall have up to two de novo lesions in different epicardial vessels (One lesion in each coronary artery or it's major branch),Target lesion shall have visually estimated diameter stenosis ≥ 70% (or ≥ 50% and has clinical evidence of myocardial ischemia), lesion length ≤ 24mm, reference vascular diameter visually ≥ 2.75mm and ≤ 4.0mm. And subjects must meet all the study inclusion / exclusion criteria before enrolment in the study.All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post procedure.
Detailed description
This is a Multi Center Randomized (MeRes:XIENCE=1:1) Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in treatment of approximately 484 subjects with Coronary Artery Disease in China. The post marketed XIENCE Everolimus Eluting Coronary Stent System will serve as the control device, to evaluate the safety and efficacy of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in coronary artery disease, and to support the product registration approval of the China Food and Drug Administration (CFDA).
Eligible subjects shall have up to two de novo lesions in different epicardial vessels ( One lesion in each coronary artery or it's major branch),Target lesion shall have visually estimated diameter stenosis ≥ 70% (or ≥ 50% and has clinical evidence of myocardial ischemia), lesion length ≤ 24mm, reference vascular diameter visually ≥ 2.75mm and ≤ 4.0mm. And subjects must meet all the study inclusion / exclusion criteria before enrolment in the study.
All the subjects shall accept angiography follow up at 12 months post procedure.
OCT subgroup ((N=80, 40 from test group and 40 from control group) shall accept follow up of OCT at immediately and 12 months post procedure. In segment late lumen loss at 12 months post procedure is the primary endpoint, and the percentage of stent strut neointimal coverage assessed with OCT at 12 months post procedure is the key secondary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 Randomization of Study Device and Control
| Arm | Type | Receives |
|---|---|---|
| MeRes100 BRS | Experimental | Device: MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System, Device: Xience EES Everolimus Eluting Coronary Stent SystemMeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System indicated for the treatment of coronary artery disease along with standard percutaneous angioplasty procedure. |
| Xience EES | Active comparator | Device: MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System, Device: Xience EES Everolimus Eluting Coronary Stent SystemXience EES is a Everolimus Eluting Coronary Stent System indicated for the treatment of coronary artery disease along with standard percutaneous angioplasty procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- General inclusion criteria:
- One de novo target lesion or up-to two de novo target lesions in different epicardial vessels: Different epicardial vessels are defined as left anterior descending artery (LAD) and its branches, left circumflex artery (LCX) arteries and its branches, and right coronary arteries (RCA) and its branches. Thus, for example, the subject must not have two target lesions required to be treated at the LAD and its branches at the same time.
- Target lesion diameter stenosis ≥ 70% (or ≥ 50% simultaneously shall have clinical evidence of myocardial ischemia), and TIMI flow grade ≥1.
- Target lesion length ≤ 24mm (estimated visually); reference vessel diameter between ≥ 2.75 mm to ≤ 4.00 mm.
- Each target lesion can be fully covered by one scaffold.
Key exclusion criteria (49 listed)
- General exclusion criteria:
- / dl (132.6μmol / L) or subject is receiving hemodialysis, ALT or AST were three times greater than the upper limit of normal.
- Subjects with coronary artery triple vessel lesion in LAD, LCX or RCA, all need to be treated.
- Target lesion locates in left main.
- Target lesion locates in the aorto-ostial of RCA (within 3 mm of the origin of the RCA).
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 used in the treatment of patients with coronary artery disease along with standard percutaneous angioplasty procedure. | Device | MeRes100 BRS, Xience EES |
| Xience EES Everolimus Eluting Coronary Stent SystemXience EES Everolimus Eluting Coronary Stent System indicated for the treatment of coronary artery disease along with standard percutaneous angioplasty procedure. | Device | MeRes100 BRS, Xience EES |
Primary outcome
In-segment Late Lumen Loss
Time frame: 12 Months
Angiographic analysis for measuring Late Lumen Loss in both the treatment group
1 secondary outcome
The percentage of stent strut neointimal coverage assessed with OCT
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Gao Runlin, MD principal investigator
Fuwai Hospital CAMS
Questions about this trial
What is this clinical trial studying?
A study testing MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System and Xience EES Everolimus Eluting Coronary Stent System in people with Coronary Artery Disease, run by Meril Life Sciences Pvt. Ltd..
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 9 inclusion and 49 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 14 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imrankhan M Lohani, M.Sc. (9619608544, Imrankhan.lohani@merillife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-segment Late Lumen Loss (time frame: 12 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 14 Aug 2019.