Safety and Effectiveness of the Coronary Momo Stent

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01535625
• Date of registration: 15/02/2012
• Prospective Registration: No
• Primary sponsor: be Medical
• Public title: Safety and Effectiveness of the Coronary Momo Stent
• Scientific title: Clinical Evaluation of the Momo Cobalt-Chromium Coronary Stent System for the Treatment of Patients With Coronary Artery Disease
• Date of first enrolment: February 2012
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01535625
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Belgium

Contacts

• Name: Luc Janssens, MD
• Affiliation: Imelda vzw

• Name: Luc Janssens, MD

Key inclusion & exclusion 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.).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

Device: Momo stent

Primary Outcome(s)

6-month angiography [Time Frame: 6 months]

Secondary Outcome(s)

MACE [Time Frame: 1 month, 6 months, 12 months]

Major adverse cardiac events [Time Frame: 6 months]

Secondary ID(s)

BM-MOMO-04-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Japan Stent Technology Europe GmbH