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Safety and Effectiveness of the Coronary Momo Stent

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by be Medical.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Japan Stent Technology Europe GmbH
Information provided by (Responsible Party):
be Medical
ClinicalTrials.gov Identifier:
NCT01535625
First received: February 15, 2012
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Momo stent
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Momo Cobalt-Chromium Coronary Stent System for the Treatment of Patients With Coronary Artery Disease

Further study details as provided by be Medical:

Primary Outcome Measures:
  • 6-month angiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Binary restenosis(defined as >50% diameter stenosis by QCA), late loss, percent diameter stenosis, minimal lumen diameter


Secondary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    including death, recurrent non-fatal myocardial infarction, emergent CABG and/or clinically driven target vessel revascularization

  • MACE [ Time Frame: 1 month, 6 months, 12 months ] [ Designated as safety issue: Yes ]
    Including death, recurrent non-fatal myocardial infarction, emergent CABG and/or clinically driven target vessel revascularization, target lesion revascularization (TLR), target vessel revascularization (TVR), target vessel failure (TVF) and stent thrombosis


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Momo stent
Patients with PCI
Device: Momo stent
Patients with PCI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Patients who are eligible for coronary revascularization by angioplasty and stenting and by CABG (if required as bail-out).
  3. Patients with a de novo lesion in a native coronary artery between > 50 % and < 100 % stenosis.
  4. 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.

  5. Target vessel suitable for implantation of a single stent with a target vessel diameter of ≥ 2.5 mm and lesion length < 20 mm.
  6. Patients with left ventricular ejection fraction (LVEF) of > 30 %.
  7. Patients willing to sign a written informed consent prior to participation and willing to be compliant with all requested follow-up evaluations.

Exclusion Criteria:

  1. Patients under the age of 18 or unable to give informed consent.
  2. Women of child bearing potential.
  3. Patients who currently participate in another study (whatever the subject of that study is).
  4. 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.
  5. Patients with a life expectancy of less than 24 months or factors making clinical and/or angiographic follow-up difficult (no fixed address, etc.).
  6. Patients who intend to have a major (as per principal investigators' medical judgment) surgical intervention within 6 months of enrolment in the study.
  7. 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.
  8. Patients with a contraindication to emergency coronary bypass surgery.
  9. Any individual who may refuse a blood transfusion.
  10. Patients with serum creatinine > 2.0 mg/dl or (> 180 µmol/l).
  11. Patients with a baseline platelet count less than 100,000 platelets/mm³.
  12. Patients with intolerance or contraindication to acetylsalicylic acid (aspirin), heparin, clopidogrel or ticlopidine drug therapy.
  13. Patients with contrast agent hypersensitivity that cannot be adequately pre-medicated.
  14. Patients whose target vessel has been stented before.
  15. Any procedure to treat another coronary artery scheduled within 6 months after implantation of the study stent.

Exclusion criteria related to angiography

  1. Patients with previous PCI of the same segment (i.e. no restenotic lesions).
  2. Any previous interventional procedure (less than 6 months) anywhere within the target vessel.
  3. Target lesion is located in or supplied by an arterial or venous bypass graft
  4. Target lesion involves a side branch ≥ 2.0 mm in diameter.
  5. Ostial target lesion (within 3.0 mm of vessel origin).
  6. Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment.
  7. Patients with total occlusions (TIMI 0).
  8. Significant (>50%) stenosis proximal or distal to the target lesion than might require revascularization or impede run off.
  9. Target lesion requires treatment with a device other than the predilatation balloon prior to stent placement (including but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, cutting balloon etc.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535625

Contacts
Contact: Luc Janssens, MD +32 15 50 61 91 Luc.Janssens@imelda.be

Locations
Belgium
ZNA Middelheim Recruiting
Antwerpen, Belgium
Principal Investigator: Paul Vermeersch, MD         
Imelda vzw Recruiting
Bonheiden, Belgium
Principal Investigator: Luc Janssens, MD         
AZ Sint Jan Recruiting
Brugge, Belgium
Principal Investigator: Patrick Coussement, MD         
UZ Brussel Recruiting
Brussel, Belgium
Principal Investigator: Oscar Semeraro, MD         
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium
Principal Investigator: Mathias Vrolix, MD         
AZ Maria Middelares Recruiting
Gent, Belgium
Principal Investigator: Kristoff Cornelis, MD         
Sponsors and Collaborators
be Medical
Japan Stent Technology Europe GmbH
Investigators
Principal Investigator: Luc Janssens, MD Imelda vzw
  More Information

No publications provided

Responsible Party: be Medical
ClinicalTrials.gov Identifier: NCT01535625     History of Changes
Other Study ID Numbers: BM-MOMO-04-001
Study First Received: February 15, 2012
Last Updated: February 17, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by be Medical:
Coronary artery disease
Atherosclerosis
CAD

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014