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

NCT00689767 | Terminated DMC

• 2 other identifiers: 801Application #: 2008-001347-20
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 7

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.

Conditions

Coronary Artery Disease

Keywords

drug eluting stent

Outcome Measures

Primary Outcomes (1)

• Late Lumen Loss

  6 months

Study Arms (2)

A

EXPERIMENTAL

This arm will receive the coated stent

Device: CINATRA™ ISA 247 Coated Coronary Stent System

B

ACTIVE COMPARATOR

This arm will receive a bare metal stent

Device: CINATRA™ Coronary Stent System

Interventions

CINATRA™ Coronary Stent System DEVICE

Bare metal cobalt chromium stent implantation

B

CINATRA™ ISA 247 Coated Coronary Stent System DEVICE

Drug coated cobalt chromium stent implantation

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who are eligible for coronary revascularization (percutanous angioplasty).
• Acceptable candidates for coronary artery bypass grafting (CABG).
• 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.
• The target lesion must be a maximum length of 13 mm (visual estimate) and able to be covered by one stent.
• The reference diameter of the target lesion must be 3.0 mm by visual estimate.
• Left ventricular ejection fraction of \>30%.
• Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.

You may not qualify if:

• Patients under the age of 18 or unable to give informed consent.
• 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.
• Patients who previously participated in this study.
• 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.
• Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult (no fixed address, etc.).
• Patients who intend to have a major surgical intervention within 6 months of enrollment in the study.
• Patients with new ST elevation within 48 hours prior to stenting.
• Braunwald Class IA, IIA and IIIA angina pectoris.
• Patients with a contraindication to an emergency coronary bypass surgery.
• Patients who had previous Coronary Artery Bypass Surgery (CABG).
• Any individual who may refuse a blood transfusion.
• Serum creatinine \>3.0 mg/dL.
• Platelet count \<100,000 cells/mm³.
• Patients with intolerance or contraindication to acetylsalicylic acid (aspirin), heparin, cyclosporin or cyclosporine derivative, clopidogrel or ticlopidine drug therapy.

Sponsors & Collaborators

• Atrium Medical Corporation: lead

Study Sites (7)

Middelheim Hospital

Antwerp, Belgium

Location

Imelda ziekenhuis

Bonheiden, 2820, Belgium

Location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Ziekenhuis Oost Limburg, Campus Sint Jan

Genk, 3600, Belgium

Location

Algemeen Ziekenhuis Maria Middelares

Ghent, 9000, Belgium

Location

Virga Jesse Ziekenhuis

Hasselt, 3500, Belgium

Location

UZ Leuven Cardiovascular Institute

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Glenn Van Langenhove, MD

  Middelheim Hospital, Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 4, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2012
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

BE (7)