Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System

NCT02663323 | Unknown DMC

• 1 other identifier: MER/EX
• Study Type: interventional
• Target: 64
• Locations: 4 countries
• Sites: 4

Brief 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. 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

Keywords

Coronary Artery Disease; MeRes-1 Extend; MeRes100; Sirolimus Eluting Bioresorbable Vascular Scaffold System

Outcome Measures

Primary Outcomes (2)

• Primary Clinical Endpoint: Proportion of population reporting with Major Adverse Cardiac Event at 6 months from the day of index procedure.

  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

  6 Month

Study Arms (1)

MeRes100 - BRS

EXPERIMENTAL

MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System

Device: MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System

Interventions

MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System DEVICE

MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the treatment of de-novo coronary artery lesions.

MeRes100 - BRS

Eligibility Criteria

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

You may qualify if:

• 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)
• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Meril Life Sciences Pvt. Ltd.: lead

Study Sites (4)

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, 04012-909, Brazil

Location

Medistra Hospital

Jakarta, 12950, Indonesia

Location

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

University Clinic of Cardiology

Skopje, 1000, North Macedonia

Location

Related Publications (1)

• 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.

  PMID: 33269506 DERIVED

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

• Dr. Alexandre Abizaid

  Dante Pazzanese Hospital, Sao Paulo, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single intervention with MeRes100 Device

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: January 26, 2016
• Study Start: February 2, 2016
• Primary Completion: October 5, 2017
• Study Completion: July 5, 2020
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); BR (1); MY (1); ID (1)