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| Sponsor: | Lutonix, Inc. |
|---|---|
| Information provided by (Responsible Party): | Lutonix, Inc. |
| ClinicalTrials.gov Identifier: | NCT00916279 |
Purpose
The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in the native coronary system. Angiographic and clinical outcomes will be assessed.
| Condition | Intervention | Phase |
|---|---|---|
|
In-Stent Restenosis |
Device: Lutonix Paclitaxel-Coated Balloon |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis Within Bare-Metal Stents |
| Enrollment: | 41 |
| Study Start Date: | June 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lutonix Catheter |
Device: Lutonix Paclitaxel-Coated Balloon
PTCA
Other Name: Drug Coated Balloon
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Belgium | |
| Onze Lieve Vrouw Ziekenhuis | |
| Aalst, Belgium, 9300 | |
| Germany | |
| Kerckhoff Klinik | |
| Bad Nauheim, Germany, 61231 | |
| Westdeutsches Herzzentrum Essen | |
| Essen, Germany | |
| Alte Clinic Center for Cardiology | |
| Hamburg, Germany, 22527 | |
| Herzzentrum Leipzig GmbH | |
| Leipzig, Germany | |
| Netherlands | |
| Academic Medical Center | |
| Amsterdam, Netherlands | |
| Catherina Ziekenhuis | |
| Eindhoven, Netherlands | |
| Sint Antonius Ziehenhuis | |
| Nieuwegein, Netherlands | |
| Principal Investigator: | Laura Mauri, MD | Brigham & Women's Hospital, Boston, MA |
More Information
| Responsible Party: | Lutonix, Inc. |
| ClinicalTrials.gov Identifier: | NCT00916279 History of Changes |
| Other Study ID Numbers: | CL0010-01 |
| Study First Received: | June 4, 2009 |
| Last Updated: | April 3, 2012 |
| Health Authority: | Germany: Ethics Commission |
|
Bare Metal In-Stent Restenosis Paclitaxel Coated Balloon Catheter Drug Coated Balloon Coronary Artery Disease |
|
Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |