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Sponsored by: |
Minnow Medical, Inc. |
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Information provided by: | Minnow Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT00751283 |
The purpose of this study is to evaluate the safety and efficacy of the Minnow Medical GRST Peripheral Catheter System in the treatment of new lesions in the superficial femoral artery or the popliteal artery.
Condition | Intervention | Phase |
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Peripheral Vascular Disease |
Device: GRST Peripheral Catheter System |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Minnow Medical GRST Peripheral Catheter System First-in-Man Study Radiofrequency for the Treatment of Peripheral Vascular Occlusive Disease of the Lower Extremities |
Estimated Enrollment: | 50 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
GRST Peripheral Catheter System
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Device: GRST Peripheral Catheter System
Treatment to dilate stenoses and reduce plaque in treated vessels
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eric Koehler | ekoehler@minnowmedical.com |
Argentina | |
Clinica La Sagrada Familia | Active, not recruiting |
Buenos Aires, Argentina | |
Chile | |
Hospital Clinico de la Pontificia Universidad Catolica de Chile | Active, not recruiting |
Santiago, Chile | |
Germany | |
Universität Leipzig Herzzentrum | Recruiting |
Leipzig, Germany | |
Contact: Jacqueline Sax saxj@med.uni-leipzig.de | |
Principal Investigator: Dierk Scheinert, MD |
Principal Investigator: | Dierk Scheinert, MD | Universität Leipzig Herzzentrum |
Responsible Party: | Minnow Medical, Inc. ( Eric Koehler / Director of Clinical Studies ) |
Study ID Numbers: | DR0052 |
Study First Received: | September 9, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00751283 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Chile: Comisión Nacional de Investigación Científica y Tecnológica; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Peripheral Vascular Diseases Vascular Diseases |
Cardiovascular Diseases |