- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01535625
Safety and Effectiveness of the Coronary Momo Stent
February 17, 2012 updated by: be Medical
Clinical Evaluation of the Momo Cobalt-Chromium Coronary Stent System for the Treatment of Patients With Coronary Artery Disease
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Luc Janssens, MD
- Phone Number: +32 15 50 61 91
- Email: Luc.Janssens@imelda.be
Study Locations
-
-
-
Antwerpen, Belgium
- Recruiting
- ZNA Middelheim
-
Principal Investigator:
- Paul Vermeersch, MD
-
Bonheiden, Belgium
- Recruiting
- Imelda VZW
-
Principal Investigator:
- Luc Janssens, MD
-
Brugge, Belgium
- Recruiting
- AZ Sint Jan
-
Principal Investigator:
- Patrick Coussement, MD
-
Brussel, Belgium
- Recruiting
- UZ Brussel
-
Principal Investigator:
- Oscar Semeraro, MD
-
Genk, Belgium
- Recruiting
- Ziekenhuis Oost-Limburg
-
Principal Investigator:
- Mathias Vrolix, MD
-
Gent, Belgium
- Recruiting
- AZ Maria Middelares
-
Principal Investigator:
- Kristoff Cornelis, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Exclusion criteria related to angiography
- Patients with previous PCI of the same segment (i.e. no restenotic lesions).
- Any previous interventional procedure (less than 6 months) anywhere within the target vessel.
- Target lesion is located in or supplied by an arterial or venous bypass graft
- Target lesion involves a side branch ≥ 2.0 mm in diameter.
- Ostial target lesion (within 3.0 mm of vessel origin).
- Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment.
- Patients with total occlusions (TIMI 0).
- Significant (>50%) stenosis proximal or distal to the target lesion than might require revascularization or impede run off.
- 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.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Momo stent
Patients with PCI
|
Patients with PCI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6-month angiography
Time Frame: 6 months
|
Binary restenosis(defined as >50% diameter stenosis by QCA), late loss, percent diameter stenosis, minimal lumen diameter
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiac events
Time Frame: 6 months
|
including death, recurrent non-fatal myocardial infarction, emergent CABG and/or clinically driven target vessel revascularization
|
6 months
|
MACE
Time Frame: 1 month, 6 months, 12 months
|
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
|
1 month, 6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Luc Janssens, MD, Imelda VZW
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Anticipated)
January 1, 2013
Study Completion (Anticipated)
July 1, 2013
Study Registration Dates
First Submitted
February 15, 2012
First Submitted That Met QC Criteria
February 17, 2012
First Posted (Estimate)
February 20, 2012
Study Record Updates
Last Update Posted (Estimate)
February 20, 2012
Last Update Submitted That Met QC Criteria
February 17, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BM-MOMO-04-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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