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Sponsors and Collaborators: |
Heart Centre Rotenburg B. Braun Melsungen AG |
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Information provided by: | Heart Centre Rotenburg |
ClinicalTrials.gov Identifier: | NCT00747357 |
The INDICOR study is a controlled, prospective, multicenter, randomized, two arm phase-II real world study assessing the acute, 6 months, and 12 months and 3 year outcome of cobalt-chromium stent (Coroflex Blue) deployment followed by Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) and of Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) followed by cobalt-chromium stent (Coroflex Blue) deployment for the treatment of de-novo and restenotic lesions in native coronary arteries. The study will be conducted in India.
Condition | Intervention | Phase |
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Coronary Heart Diseases |
Device: Drug Eluting Balloon SeQuent Please |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Paclitaxel-Eluting PTCA-Balloon Catheter in Combination With a Cobalt-Chromium Stent to Treat Coronary Artery Disease in a Real World Scenario |
Estimated Enrollment: | 125 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Balloon first
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Device: Drug Eluting Balloon SeQuent Please
Drug Eluting Balloon is followed by Bare Metal Stent
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2: Experimental
Stent First
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Device: Drug Eluting Balloon SeQuent Please
Bare Metal Stent followed by Drug Eluting Balloon
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The aim of the study is to evaluate the efficacy and safety of cobalt-chromium stent (Coroflex Blue) deployment followed by Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) and of Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) followed by cobalt-chromium stent (Coroflex Blue) deployment in a real world scenario including up to two de-novo or restenotic lesions ( no in-stent restenoses) in two different native coronary arteries (reference diameter: 2.5mm and 4.0mm, length of stenosis 10mm and 25mm) for procedural success and preservation of vessel patency up to 3 years
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Lesion Related (relates to up to 2 stenoses in two different coronary arteries to be treated per protocol)
Exclusion Criteria:
Patient Related
Lesion Related
Contact: Upendra Kaul, Dr. | +91 9811150518 | ukaul@vsnl.com |
India | |
Upendra Kaul | Recruiting |
New Delhi, India, 110025 | |
Contact: Upendra Kaul, Dr +919811150518 ukaul@vsnl.com | |
Principal Investigator: Upendra Kaul, Dr. |
Principal Investigator: | Upendra kAUL, Dr. | Fortis Flt.Lt.Rajan Dhall Hospital, New Delhi, India |
Responsible Party: | B. Braun Melsungen AG ( Indranil Mukherjee ) |
Study ID Numbers: | BBM-VS-57INDICOR/CRI/07-02/n-c |
Study First Received: | September 4, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00747357 |
Health Authority: | India: Institutional Review Board |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Chromium Paclitaxel Cobalt |
Myocardial Ischemia Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |