COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00689767
Recruitment Status : Terminated (Terminated ahead of schedule after completion of the 3-year follow-up time point due to Sponsor decision.)
First Posted : June 4, 2008
Last Update Posted : April 17, 2013
Information provided by (Responsible Party):
Atrium Medical Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Device: CINATRA™ Coronary Stent System Device: CINATRA™ ISA 247 Coated Coronary Stent System Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms
Study Start Date : June 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Late Lumen Loss [ Time Frame: 6 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00689767

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Glenn Van Langenhove, MD Middelheim Hospital, Antwerp, Belgium

Layout table for additonal information
Responsible Party: Atrium Medical Corporation Identifier: NCT00689767    
Other Study ID Numbers: 801
Application #: 2008-001347-20
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013
Keywords provided by Atrium Medical Corporation:
drug eluting stent
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Calcineurin Inhibitors