NCT02112981

Brief Summary

meriT-V is a Prospective,active control open lable clinical trial to compare safety \& efficacy of BioMime Sirolimus stent Vs. Xience family of Everolimus stent by random assignment for treatment of coronary artery disease at multiple multinational centres.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
9 countries

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

November 5, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2017

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

March 22, 2014

Last Update Submit

August 16, 2018

Conditions

Coronary Artery Disease

Keywords

Coronary Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

  • To assess in-stent Late Lumen Loss

    The primary outcome of this study is to assess in-stent Late Lumen Loss at 9 months for both treatment strategies.

    9 months

Secondary Outcomes (4)

  • Frequency of Binary restenosis by Angiography

    9 months

  • Minimum Lumen Diameter by Angiography

    9 months

  • In-segment Late Lumen Loss at 9 months

    9 months

  • Clinical Evaluation

    1, 5, 9, 12 and 24 months

Study Arms (2)

Sirolimus Eluting Coronary Stent

EXPERIMENTAL

BioMime Sirolimus Eluting Stent of Meril Life Sciences

Device: Sirolimus Eluting Coronary Stent

Everolimus-eluting Coronary stent

ACTIVE COMPARATOR

XIENCE family (V, Xpedition or Prime) of Everolimus-eluting stent system of Abbott Vascular Inc.

Device: Everolimus-eluting Coronary stent

Interventions

Sirolimus Eluting Coronary StentDEVICE

BioMimeTM Sirolimus Eluting Stent (CE Marked) has cobalt chromium NexGenTM platform (CE Marked) with Tamarin BlueTM balloon Delivery System (CE marked and with FDA clearance under 510k). Stent is coated with combination of Sirolimus drug and Biodegradable PLLA and PDLG polymers.

Also known as: BioMime Sirolimus Eluting Stent
Sirolimus Eluting Coronary Stent
Everolimus-eluting Coronary stentDEVICE

Xience V/Xience Xpedition/Xience Prime stent is MULTI-LINK MINI VISION or MULTI-LINK VISION platform Cobalt chromium stent with Everolimus (active ingredient) embedded in a non-erodible polymer (inactive ingredient).

Also known as: XIENCE family of Everolimus-eluting stent
Everolimus-eluting Coronary stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be ≥18 years of age.
  • Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
  • The patient has a planned intervention of up to two de-novo native lesions
  • Target lesion reference diameter ≥ 2.5 mm and ≤ 3.5 mm in diameter (visually estimated)
  • The target lesion length is less than or equal to 46 mm (visually estimated)
  • Patient willing to provide written informed consent.
  • If the patient is a female, she should be without childbearing potential who has undergone surgical sterilization or is post-menopausal.
  • The patient and the patient's physician agree to the follow-up visits including a 9 month angiographic follow-up.

You may not qualify if:

  • Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure, unless the CK and CK-MB enzymes are less than twice the Upper Normal Limit.
  • The patient has a known hypersensitivity or contraindication to any of the requisite medications including aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus, everolimus.
  • There is an untreated significant lesion of \> 40% diameter stenosis remaining proximal or distal to the target site after the planned intervention.
  • Previous placement of any stent at the target lesion and/or within 10 mm of the target lesion.
  • Lesion with a significant side branch (branch diameter \>2 mm) that would be covered by stenting
  • Total occlusion or TIMI 0 coronary flow in the target vessel.
  • Left Main coronary artery disease (stenosis \>50%)
  • The proximal target vessel or target lesion is severely calcified by visual assessment.
  • Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the LAD or LCX.
  • The patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • The patient suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleed within the past 6 months
  • The patient has renal insufficiency as determined by a creatinine of \> 2.0mg/dl or 180 µmol/l.
  • The target lesion, or the target vessel proximal to the target lesion contains thrombus
  • Documented left ventricular ejection fraction of ≤30%
  • The patient is a recipient of a heart transplant
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Imelda Ziekenhuis Cardiology

Bonheiden, Western Europe, 2820, Belgium

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, 04012-909, Brazil

Location

Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica

São Paulo, 05403-000, Brazil

Location

Instituto do Coracao do Triangulo Mineiro

Uberlândia, 38411-186, Brazil

Location

St. Anne's Univeristy Hospital Brno

Brno-střed, Brno, 656 91, Czechia

Location

Fn Brno, Jihlavska 20

Brno, 602 00, Czechia

Location

University of Latvia, Research Institute of Cardiology

Riga, Europe, LV1002, Latvia

Location

Catharina Cardiac Centre

Eindhoven, North Brabant, 5623, Netherlands

Location

Albert Schweitzer

Dordrecht, South Holland, 3300, Netherlands

Location

Isala Hospital

Zwolle, 8025, Netherlands

Location

University Clinic of Cardiology

Skopje, 1000, North Macedonia

Location

American Heart Institure S.A.

Tychy, Silesian Voivodeship, 43-100, Poland

Location

Hospital Clinic

Barcelona, Catalonia, 08036, Spain

Location

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Manchester Heart Centre

Manchester, England, M13 9WL., United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Dr. Alexandre Abizaid, Ph.D, MD

    Instituto Dante Pazzanese de Cardiologia

    PRINCIPAL INVESTIGATOR

  • Dr. Roberto V Botelho, MD

    Instituto do Coracao do Triangulo Mineiro

    PRINCIPAL INVESTIGATOR

  • Dr. Pedro Lemos, MD

    Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica

    PRINCIPAL INVESTIGATOR

  • Dr. Expedito Ribeiro, MD

    Instituto do Coracao - HCFMUSP Centro de Pesquisa Clinica

    PRINCIPAL INVESTIGATOR

  • Dr. Elvin Kedhi, Ph.D, MBBS

    Isala

    PRINCIPAL INVESTIGATOR

  • Dr. Pim Tonino, MD

    Catharina Cardiac Centre

    PRINCIPAL INVESTIGATOR

  • Dr. Floris Kauer, MD

    Albert Schweitzer

    PRINCIPAL INVESTIGATOR

  • Dr. Luc Janssen, MD

    Imelda Ziekenhuis Cardiology

    PRINCIPAL INVESTIGATOR

  • Dr. Farzin F Ordoubadi, B.Sc, MB BCHIR, MRCP, MD, FRCP

    Manchester Heart Centre

    PRINCIPAL INVESTIGATOR

  • Dr. Suneel Talwar, MBBS, MRCP, MD

    Royal Bournemouth Hospital

    PRINCIPAL INVESTIGATOR

  • Dr. Monica Masotti, MD

    Hospital Clinic

    PRINCIPAL INVESTIGATOR

  • Dr. Andrejs Erglis, MD

    University of Latvia, Research Institute of Cardiology

    PRINCIPAL INVESTIGATOR

  • Prof. Sasko Kedev, Ph.D, MD, FESC, FACC

    University Clinic of Cardiology

    PRINCIPAL INVESTIGATOR

  • Dr. Ota Hlinomaz, Ph.D, MD

    St. Anne's Univeristy Hospital Brno

    PRINCIPAL INVESTIGATOR

  • Dr. Petr kala, Ph.D, MD, FESC, FSCAI

    Fn Brno, Jihlavska 20

    PRINCIPAL INVESTIGATOR

  • Dr. Krzysztof Milewski, Ph.D, MD

    American Heart Institure S.A.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: BioMime Sirolimus Eluting Stent system compared to the Abbott XIENCE family (V, Xpedition or Prime) of Everolimus Eluting Stent system
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2014

First Posted

April 14, 2014

Study Start

November 5, 2014

Primary Completion

September 6, 2017

Study Completion

December 1, 2019

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

CZ(2)BR(3)LA(1)NL(3)ES(1)NO(1)BE(1)PL(1)GB(2)