Safety and Effectiveness of the Coronary Momo Stent

NCT01535625 | Unknown Phase 4 DMC

• 1 other identifier: BM-MOMO-04-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

This study evaluates the safety and effectiveness of the Momo Cobalt Chromium stent system for the treatment of single de novo lesions in a native coronary artery. The stent is coated with diamond-like carbon to decrease the risk of acute and late stent thrombosis, to increase the resistance towards corrosion and to significantly improve endothelialisation through the inhibition of elution of metallic ions.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Atherosclerosis; CAD

Outcome Measures

Primary Outcomes (1)

• 6-month angiography

  Binary restenosis(defined as \>50% diameter stenosis by QCA), late loss, percent diameter stenosis, minimal lumen diameter

  6 months

Secondary Outcomes (2)

• Major adverse cardiac events

  6 months

• MACE

  1 month, 6 months, 12 months

Study Arms (1)

Momo stent

OTHER

Patients with PCI

Device: Momo stent

Interventions

Momo stent DEVICE

Patients with PCI

Momo stent

Eligibility Criteria

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

You may qualify if:

• Patients with stable angina pectoris (Canadian Cardiovascular Society \[CCS\] I to IV) or unstable angina pectoris (Braunwald classification IB-C, IIB-C or IIIB-C) or patients with documented silent ischemia.
• Patients who are eligible for coronary revascularization by angioplasty and stenting and by CABG (if required as bail-out).
• Patients with a de novo lesion in a native coronary artery between \> 50 % and \< 100 % stenosis.
• One or two heart vessel disease with a maximum of 2 lesions to be treated by stenting.
• Both lesions have to be treated with study stents.
• Target vessel suitable for implantation of a single stent with a target vessel diameter of ≥ 2.5 mm and lesion length \< 20 mm.
• Patients with left ventricular ejection fraction (LVEF) of \> 30 %.
• Patients willing to sign a written informed consent prior to participation and willing to be compliant with all requested follow-up evaluations.

You may not qualify if:

• Patients under the age of 18 or unable to give informed consent.
• Women of child bearing potential.
• Patients who currently participate in another study (whatever the subject of that study is).
• Patients who participated in another investigational cardiovascular drug or device study, which have not completed the primary endpoint follow-up period within the past 30 days.
• Patients with a life expectancy of less than 24 months or factors making clinical and/or angiographic follow-up difficult (no fixed address, etc.).
• Patients who intend to have a major (as per principal investigators' medical judgment) surgical intervention within 6 months of enrolment in the study.
• Patients with an episode of sustained ischemic chest pain exceeding 15 minutes duration within 24 hours prior to stenting or patients with new ST elevation within 48 hours prior to stenting.
• Patients with a contraindication to emergency coronary bypass surgery.
• Any individual who may refuse a blood transfusion.
• Patients with serum creatinine \> 2.0 mg/dl or (\> 180 µmol/l).
• Patients with a baseline platelet count less than 100,000 platelets/mm³.
• Patients with intolerance or contraindication to acetylsalicylic acid (aspirin), heparin, clopidogrel or ticlopidine drug therapy.
• Patients with contrast agent hypersensitivity that cannot be adequately pre-medicated.
• Patients whose target vessel has been stented before.
• Any procedure to treat another coronary artery scheduled within 6 months after implantation of the study stent.

Sponsors & Collaborators

• be Medical: lead
• Japan Stent Technology Europe GmbH: collaborator

Study Sites (6)

ZNA Middelheim

Antwerp, Belgium

RECRUITING

Imelda vzw

Bonheiden, Belgium

RECRUITING

AZ Sint Jan

Bruges, Belgium

RECRUITING

UZ Brussel

Brussels, Belgium

RECRUITING

Ziekenhuis Oost-Limburg

Genk, Belgium

RECRUITING

AZ Maria Middelares

Ghent, Belgium

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Luc Janssens, MD

  Imelda vzw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luc Janssens, MD

CONTACT

+32 15 50 61 91; Luc.Janssens@imelda.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: February 20, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 20, 2012

Record last verified: 2012-02

Locations

BE (6)