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Coronary Artery DiseasePhase 4NCT01535625

Safety and Effectiveness of the Coronary Momo Stent

A Phase 4 study testing Momo stent in people with Coronary Artery Disease, run by be Medical at 6 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Momo stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
6 sitesBelgium
Study dates
Feb 2012to Jul 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.).

Trial locations and contacts

6 sites in 1 country.

Luc Janssens, MD contact

+32 15 50 61 91

Luc.Janssens@imelda.be

6 sites in 1 country

Belgium6 sites, 6 recruiting

  • ZNA Middelheim

    Antwerp

    Paul Vermeersch, MD

    Recruiting

  • Imelda vzw

    Bonheiden

    Luc Janssens, MD

    Recruiting

  • AZ Sint Jan

    Bruges

    Patrick Coussement, MD

    Recruiting

  • UZ Brussel

    Brussels

    Oscar Semeraro, MD

    Recruiting

  • Ziekenhuis Oost-Limburg

    Genk

    Mathias Vrolix, MD

    Recruiting

  • AZ Maria Middelares

    Ghent

    Kristoff Cornelis, MD

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Being tested
Momo stent
Keywords
Coronary artery disease, Atherosclerosis, CAD
Medical subject headings
Coronary Artery Disease, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Momo stentDevice

    Patients with PCI

Study groups in NCT01535625
Study groupRoleWhat they receive
Momo stentOtherPatients with PCI
Receives: Device: Momo stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-month angiography

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

    Measured: 6 months

Secondary outcomes (2)

  1. Major adverse cardiac events

    including death, recurrent non-fatal myocardial infarction, emergent CABG and/or clinically driven target vessel revascularization

    Measured: 6 months

  2. MACE

    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

    Measured: 1 month, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionJan 2013 (estimated)
  4. Study completionJul 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01535625
Sponsor's protocol ID
BM-MOMO-04-001
Status last verified
Feb 2012
First submitted
15 Feb 2012
Last updated
20 Feb 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Momo stent in people with Coronary Artery Disease, run by be Medical at 6 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Luc Janssens, MD (+32 15 50 61 91, Luc.Janssens@imelda.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month angiography (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01535625.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2012.

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