COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms (CONFIRM 1)
Tracking Information | |||||
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First Received Date ICMJE | June 2, 2008 | ||||
Last Updated Date | January 27, 2012 | ||||
Start Date ICMJE | June 2008 | ||||
Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Late Lumen Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00689767 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms (CONFIRM 1) | ||||
Official Title ICMJE | COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms | ||||
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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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Condition ICMJE | Coronary Artery Disease | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 100 | ||||
Estimated Completion Date | February 2014 | ||||
Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Belgium | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00689767 | ||||
Other Study ID Numbers ICMJE | 801, Application #: 2008-001347-20 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Atrium Medical Corporation | ||||
Study Sponsor ICMJE | Atrium Medical Corporation | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Atrium Medical Corporation | ||||
Verification Date | January 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |