The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary Bifurcations (PEPCAD-BIF)
This study is currently recruiting participants.
Verified September 2012 by Heart Centre Rotenburg
Sponsor:
Heart Centre Rotenburg
Collaborator:
B. Braun Melsungen AG
Information provided by:
Heart Centre Rotenburg
ClinicalTrials.gov Identifier:
NCT01180517
First received: August 9, 2010
Last updated: October 1, 2012
Last verified: September 2012
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Purpose
The intention of this trial is to assess the safety and efficacy of Drug Eluting Balloon (DEB) application (SeQuent Please) to the side branch in percutaneous coronary intervention (PCI) of Medina 0,0,1 coronary bifurcation lesions. Patients will be randomized to treatment with Plain Old Balloon Angioplasty (POBA)or treatment with DEB.
| Condition | Intervention | Phase |
|---|---|---|
|
Angioplasty |
Procedure: Percutaneous coronary intervention (PCI) Procedure: PCI |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Paclitaxel-Eluting PTCA-Balloon Catheter for the Treatment of Coronary Bifurcations |
Resource links provided by NLM:
MedlinePlus related topics:
Angioplasty
Drug Information available for:
Paclitaxel
U.S. FDA Resources
Further study details as provided by Heart Centre Rotenburg:
Primary Outcome Measures:
- In-segment late lumen loss in the side branch at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2010 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Drug Eluting Balloon |
Procedure: Percutaneous coronary intervention (PCI)
balloon angioplasty
|
| Active Comparator: Plain Old Balloon Angioplasty (POBA) |
Procedure: PCI
balloon angioplasty
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria (main):
- De-novo Medina type 0,0,1 bifurcational native coronary artery lesion (reference diameter:>2.0 mm <3.5 mm, length of stenosis: ≤ 10 mm), the diameter of the side branch shall be smaller or equal to the diameter of the distal end vessel
Exclusion Criteria (main):
- Reference side branch diameter > 3.5 mm
- Evidence of extensive thrombosis within target vessel
- Patients with another coronary stent implanted previously into the target branch or bifurcation ≤ 15 mm distant to the current lesion, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEPCAD- BIF
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180517
Locations
| Germany | |
| Herzzentrum Dresden | Not yet recruiting |
| Dresden, Germany, 01307 | |
| Contact: R. H. Strasser, MD,PhD +49-351-450-1701 Ruth.Strasser@mailbox.tu-dresden.de | |
| Principal Investigator: R. H. Strasser, MD,PhD | |
| Klinikum Ernst von Bergmann | Recruiting |
| Potsdam, Germany, 14467 | |
| Contact: F. X. Kleber, MD +49-331-241-6102 fxkleber@linikumevb.de | |
| Principal Investigator: F. X. Kleber, MD | |
Sponsors and Collaborators
Heart Centre Rotenburg
B. Braun Melsungen AG
Investigators
| Principal Investigator: | F. X. Kleber, MD | Klinikum Ernst von Bergmann Potsdam, Germany |
More Information
No publications provided
| Responsible Party: | M. Boxberger, B.Braun Melsungen AG |
| ClinicalTrials.gov Identifier: | NCT01180517 History of Changes |
| Other Study ID Numbers: | AAG-G-H-1003 |
| Study First Received: | August 9, 2010 |
| Last Updated: | October 1, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Heart Centre Rotenburg:
|
Angioplasty Balloon |
Additional relevant MeSH terms:
|
Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013