Study of MeRes100 in the Treatment of Patient With Coronary Artery Disease.

NCT03454724 | Unknown

• 1 other identifier: MeRes-201706
• Study Type: interventional
• Target: 484
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Coronary Artery Disease

Keywords

BioResorbable Vascular Scaffold System

Outcome Measures

Primary Outcomes (1)

• In-segment Late Lumen Loss

  Angiographic analysis for measuring Late Lumen Loss in both the treatment group

  12 Months

Secondary Outcomes (1)

• The percentage of stent strut neointimal coverage assessed with OCT

  12 Months

Study Arms (2)

MeRes100 BRS

EXPERIMENTAL

MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System indicated for the treatment of coronary artery disease along with standard percutaneous angioplasty procedure.

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.

Device: MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System; Device: Xience EES Everolimus Eluting Coronary Stent System

Interventions

MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System DEVICE

MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System used in the treatment of patients with coronary artery disease along with standard percutaneous angioplasty procedure.

MeRes100 BRS; Xience EES

Xience EES Everolimus Eluting Coronary Stent System DEVICE

Xience EES Everolimus Eluting Coronary Stent System indicated for the treatment of coronary artery disease along with standard percutaneous angioplasty procedure.

MeRes100 BRS; Xience EES

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Meril Life Sciences Pvt. Ltd.: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gao Runlin, MD

  Fuwai Hospital CAMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imrankhan M Lohani, M.Sc.

CONTACT

9619608544; Imrankhan.lohani@merillife.com

Ashok Thakkar, Ph.D

CONTACT

9879443584; ashok.thakkar@merillife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 Randomization of Study Device and Control

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: March 6, 2018
• Study Start: January 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2024
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share