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| Sponsor: | Heart Centre Rotenburg |
|---|---|
| Collaborator: |
B. Braun Melsungen AG |
| Information provided by: | Heart Centre Rotenburg |
| ClinicalTrials.gov Identifier: | NCT00747357 |
Purpose
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 |
|---|---|---|
|
Coronary Heart Diseases |
Device: Drug Eluting Balloon SeQuent Please |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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: | April 2012 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Balloon first
|
Device: Drug Eluting Balloon SeQuent Please
Drug Eluting Balloon is followed by Bare Metal Stent
Other Name: SeQuent® Please DEB
|
|
Experimental: 2
Stent First
|
Device: Drug Eluting Balloon SeQuent Please
Bare Metal Stent followed by Drug Eluting Balloon
Other Name: SeQuent® Please DEB
|
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
Eligibility| 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
Contacts and Locations| India | |
| Upendra Kaul | |
| New Delhi, India, 110025 | |
| Principal Investigator: | Upendra kAUL, Dr. | Fortis Flt.Lt.Rajan Dhall Hospital, New Delhi, India |
More Information
| Responsible Party: | Indranil Mukherjee, B. Braun Melsungen AG |
| ClinicalTrials.gov Identifier: | NCT00747357 History of Changes |
| Other Study ID Numbers: | BBM-VS-57INDICOR/CRI/07-02/n-c |
| Study First Received: | September 4, 2008 |
| Last Updated: | May 25, 2010 |
| Health Authority: | India: Institutional Review Board |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Chromium Paclitaxel Trace Elements |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |