|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Heart Centre Rotenburg |
|---|---|
| Collaborators: |
B. Braun Melsungen AG Clinical Research Institute Rotenburg a.d.F. |
| Information provided by: | Heart Centre Rotenburg |
| ClinicalTrials.gov Identifier: | NCT00540813 |
Purpose
The aim of the study is to investigate the feasibility of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) followed by bare metal stent (Coroflex ) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 3.8 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 20 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native left coronary artery as reflected by procedural success and to evaluate the preservation of vessel patency.
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemia Stenosis |
Device: drug eluting balloon |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Paclitaxel-Eluting Balloon Angioplasty and Coroflex™-Stents in the Treatment of Bifurcated Coronary Lesions |
| Estimated Enrollment: | 25 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria: Lesion Related
Exclusion Criteria:
Exclusion Criteria: Lesion Related
Contacts and Locations| Germany | |
| F.X.Kleber | |
| Berlin, Germany, 12683 | |
| D.G: Mathey | |
| Hamburg, Germany, 22527 | |
| Principal Investigator: | D. G. Mathey, MD | Hamburg University Cardiovascular Center GmbH |
| Principal Investigator: | F. X. Kleber, MD | Department of Internal Medicine Unfallkrankenhaus Berlin |
More Information
| Responsible Party: | M. Boxberger, Project Leader, BBraun Melsungen |
| ClinicalTrials.gov Identifier: | NCT00540813 History of Changes |
| Other Study ID Numbers: | BBM-VS-56 |
| Study First Received: | October 5, 2007 |
| Last Updated: | September 18, 2008 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
bifurcation stenosis Patients with documented ischemia due to a de-novo bifurcation stenosis |
|
Constriction, Pathologic Ischemia Pathological Conditions, Anatomical Pathologic Processes Paclitaxel Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |