DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease (PEPCADIII)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital, Saarland.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University Hospital, Saarland
Collaborator:
B.Braun Vascular Systems, Berlin, Germany
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00473772
First received: May 14, 2007
Last updated: February 19, 2009
Last verified: February 2009
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | May 14, 2007 | ||||||||
| Last Updated Date | February 19, 2009 | ||||||||
| Start Date ICMJE | July 2007 | ||||||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
late lumen loss [ Time Frame: 9 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
late lumen loss [ Time Frame: 9 months ] | ||||||||
| Change History | Complete list of historical versions of study NCT00473772 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease | ||||||||
| Official Title ICMJE | Paclitaxel-Eluting PTCA-Balloon in Combination With the CoroflexTM Blue Stent vs the Sirolimus Coated CypherTM Stent in the Treatment of Advanced Coronary Artery Disease | ||||||||
| Brief Summary | The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting SeQuent Please S stent system (DEBlue) in the treatment of stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and < 24 mm in length for procedural success and preservation of vessel patency in comparison to the Sirolimus-eluting CypherTM stent. |
||||||||
| Detailed Description | The incidence of in-stent restenosis after percutaneous coronary intervention varies between 5 and 35% after bare metal stenting and is as high as 19% after the implantation of a drug-eluting stent in patients at moderate risk. Restenosis due to neointimal hyperplasia is a slow process, suggesting that therapeutic local drug administration would need to be prolonged to be beneficial. Stent-based local drug delivery provides sustained drug release using special release technologies like polymer coating. However, cell culture experiments indicate that even brief contact between vascular smooth muscle cells and lipophilic taxane compounds can inhibit vascular smooth muscle cell proliferation for a long period. In experiments in swine, intracoronary delivery of paclitaxel by contrast media or by a drug-coated balloon catheter was found to result in vascular tissue concentrations capable of producing antiproliferative effects, thus leading to a significant reduction in neointimal proliferation. In these animal studies, the most pronounced reduction of neointimal formation was seen with paclitaxel-coated balloon catheters. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Coronary Artery Disease | ||||||||
| Intervention ICMJE | Device: DEBlue stent vs. Cypher stent
DES vs. DEB with BMS |
||||||||
| Study Arm (s) |
|
||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 643 | ||||||||
| Estimated Completion Date | January 2011 | ||||||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| 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, Czech Republic, France, Germany, Netherlands, Spain, Sweden, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00473772 | ||||||||
| Other Study ID Numbers ICMJE | BBM-VS-54 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dr. Michael Boxberger, B.Braun Vascular Systems, Berlin, Germany | ||||||||
| Study Sponsor ICMJE | University Hospital, Saarland | ||||||||
| Collaborators ICMJE | B.Braun Vascular Systems, Berlin, Germany | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University Hospital, Saarland | ||||||||
| Verification Date | February 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||