COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms (CONFIRM 1)

This study has been terminated.
(Terminated ahead of schedule after completion of the 3-year follow-up time point due to Sponsor decision.)
Sponsor:
Information provided by (Responsible Party):
Atrium Medical Corporation
ClinicalTrials.gov Identifier:
NCT00689767
First received: June 2, 2008
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

This First In Man study is a prospective, multicentre, single blind, randomized, controlled clinical trial of the CINATRA™ ISA 247 Coated Coronary Stent System as compared to the CINATRA™ Coronary Stent System. The study will enroll up to 100 evaluable patients at up to 7 sites. Clinical follow up will occur at 1 month, 6 months, and 1, 2, 3, 4 and 5 years post procedure. Repeat angiography and IVUS will be performed at the 6 month follow up time point for all subjects.


Condition Intervention
Coronary Artery Disease
Device: CINATRA™ Coronary Stent System
Device: CINATRA™ ISA 247 Coated Coronary Stent System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms

Resource links provided by NLM:


Further study details as provided by Atrium Medical Corporation:

Primary Outcome Measures:
  • Late Lumen Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: June 2008
Study Completion Date: July 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
This arm will receive the coated stent
Device: CINATRA™ ISA 247 Coated Coronary Stent System
Drug coated cobalt chromium stent implantation
Active Comparator: B
This arm will receive a bare metal stent
Device: CINATRA™ Coronary Stent System
Bare metal cobalt chromium stent implantation

  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 1, 2, 3) or unstable angina pectoris with documented ischemia (CCS 4, Braunwald Class IB-C, IIB-C or IIIB-C), or patients with documented silent ischemia.
  2. Patients who are eligible for coronary revascularization (percutanous angioplasty).
  3. Acceptable candidates for coronary artery bypass grafting (CABG).
  4. Patients with de novo lesion in a native coronary artery >50% and <100% stenosis.

    NOTE: Treatment of lesions in a non-target vessel is up to the investigator's discretion (max. two-vessel-disease).

    ONLY a bare metal stent (no drug eluting stent) can be used for this treatment. Treatment of any non-target vessel lesions must be successfully completed before enrolling patient and placing study stent.

  5. The target lesion must be a maximum length of 13 mm (visual estimate) and able to be covered by one stent.
  6. The reference diameter of the target lesion must be 3.0 mm by visual estimate.
  7. Left ventricular ejection fraction of >30%.
  8. Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.

Exclusion Criteria:

  1. Patients under the age of 18 or unable to give informed consent.
  2. Women who are pregnant. Women of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable contraception at a minimum until after the angiographic follow up.
  3. Patients who previously participated in this study.
  4. Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

    NOTE: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.

  5. Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult (no fixed address, etc.).
  6. Patients who intend to have a major surgical intervention within 6 months of enrollment in the study.
  7. Patients with new ST elevation within 48 hours prior to stenting.
  8. Braunwald Class IA, IIA and IIIA angina pectoris.
  9. Patients with a contraindication to an emergency coronary bypass surgery.
  10. Patients who had previous Coronary Artery Bypass Surgery (CABG).
  11. Any individual who may refuse a blood transfusion.
  12. Serum creatinine >3.0 mg/dL.
  13. Platelet count <100,000 cells/mm³.
  14. Patients with intolerance or contraindication to acetylsalicylic acid (aspirin), heparin, cyclosporin or cyclosporine derivative, clopidogrel or ticlopidine drug therapy.
  15. Patients with contrast agent hypersensitivity that cannot be adequately pre-medicated.
  16. Patients who have a stent anywhere within the target vessel.
  17. Any planned interventional treatment of any vessel post study procedure.

    Exclusion Criteria Related to Angiography

  18. Patients with previous PCI of the same segment (i.e. no restenotic lesions).
  19. Previous interventional procedure (less than 6 months) anywhere within the target vessel;
  20. Target lesion is located in or supplied by an arterial or venous bypass graft.
  21. Target lesion involves a side branch >2.0mm in diameter.
  22. Ostial target lesion (within 3.0mm of vessel origin).
  23. Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment .
  24. Patients with total occlusions (TIMI 0).
  25. Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off.
  26. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689767

Locations
Belgium
Middelheim Hospital
Antwerp, Belgium
Imelda ziekenhuis
Bonheiden, Belgium, 2820
Cliniques universitaires Saint-Luc
Bruxelles, Belgium, 1200
Ziekenhuis Oost Limburg, Campus Sint Jan
Genk, Belgium, 3600
Algemeen Ziekenhuis Maria Middelares
Gent, Belgium, 9000
Virga Jesse Ziekenhuis
Hasselt, Belgium, 3500
UZ Leuven Cardiovascular Institute
Leuven, Belgium, 3000
Sponsors and Collaborators
Atrium Medical Corporation
Investigators
Principal Investigator: Glenn Van Langenhove, MD Middelheim Hospital, Antwerp, Belgium
  More Information

No publications provided

Responsible Party: Atrium Medical Corporation
ClinicalTrials.gov Identifier: NCT00689767     History of Changes
Other Study ID Numbers: 801, Application #: 2008-001347-20
Study First Received: June 2, 2008
Last Updated: April 16, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Atrium Medical Corporation:
drug eluting stent

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

ClinicalTrials.gov processed this record on April 16, 2014