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| Sponsor: | University Hospital, Saarland |
|---|---|
| Information provided by (Responsible Party): | Bruno Scheller, University Hospital, Saarland |
| ClinicalTrials.gov Identifier: | NCT01084408 |
Purpose
The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary De-novo Stenoses |
Device: SeQuent®Please (Paclitaxel coated balloon) Device: Taxus™Liberté™ (Paclitaxel eluting stent) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon |
| Estimated Enrollment: | 90 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Sequent®Please |
Device: SeQuent®Please (Paclitaxel coated balloon)
PCI of de-novo lesions
|
| Active Comparator: Taxus™Liberté™ |
Device: Taxus™Liberté™ (Paclitaxel eluting stent)
PCI of de-novo lesions
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bruno Scheller, Prof. Dr.med | +49(0)6841 162 3350 | bruno.scheller@uks.eu |
| Germany | |
| Klinik für Kardiologie, Angiologie und Konservative Intensivtherapie Klinikum Ernst von Bergmann | Recruiting |
| Postdam, Brandenburg, Germany, 14467 | |
| Contact: Franz Xaver Kleber, Prof. Dr. med fxkleber@klinikumevb.de | |
| Principal Investigator: Franz Xaver Kleber, Prof. Dr. med | |
| Medizinisches Versorgungszentrum | Recruiting |
| Hamburg, Germany, 22527 | |
| Contact: Detlef Mathey, Prof. Dr. med +49(0)408890090 mathey@herz-hh.de | |
| Principal Investigator: Detlef Mathey, Prof. Dr. med | |
| Principal Investigator: | Bruno Scheller, Prof. Dr. med | Uniklinikum des Saarlandes |
More Information
| Responsible Party: | Bruno Scheller, MD, University Hospital, Saarland |
| ClinicalTrials.gov Identifier: | NCT01084408 History of Changes |
| Other Study ID Numbers: | Pac 14 |
| Study First Received: | March 9, 2010 |
| Last Updated: | November 29, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
de-novo coronary stenoses PEPCAD DEBonly Paclitaxel |
|
Constriction, Pathologic Pathological Conditions, Anatomical Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |