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Sponsored by: |
University Hospital Tuebingen |
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Information provided by: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00546845 |
This study is an investigator-initiated study. The study will be performed as a prospective, randomized, controlled multi-center trial to evaluate the safety and efficiency of Xpert stents compared to PTA in patients with chronic distal artery occlusions or stenosis undergoing catheter revascularization. Patients will be eligible for randomization if they are over 18 years old, if they undergo percutaneous catheter revascularization of an artery below the knee stenosis/occlusion that is less than 15 centimeters in length. Up to two vessels may be treated in this study. All lesions greater than 50% in the below the knee artery region have to be treated either with PTA or stenting according to the randomization.
Condition | Intervention | Phase |
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Cronic Limb Ishemia Intervention |
Device: Balloon angioplasty Device: Use of self-expanding Expert stent |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Xpert Stent Versus Balloon Angioplasty in Complex Lesions of Small Arteries Below the Knee |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | June 2009 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical:
1. Additional lesions inflow lesions might be successfully treated before randomization and treatment of the target lesion. The inflow lesions which were treated before randomization should only be classified TASC A or B. (TASC= Trans Atlantic Intersociety Conference) 2. Target vessel with documented run-off to the foot distally of the index lesion with patent plantar arteries 3. Reference vessel diameter of the target lesion should be ≥ 2 and ≤ 5 mm. 4. Maximum treated length in the target vessel is 15 cm (might also be divided up into multiple segments with up to 3 different lesions being treated). 5. Maximum of treated vessels per leg below the knee: 2 (all treated vessels should be treated within the randomization to the study group [PTA or stenting]). 6. Minimum distance target lesion to talus is 5 cm.
Exclusion Criteria:
Clinical
Anatomical:
Contact: Gunnar Tepe, MD | 49 7071 2983371 | gunnar.tepe@med.uni-tuebingen.de |
Contact: Jane Gollub | 49 7071 2983371 | jane.gollub@med.uni-tuebingen.de |
Germany, BW | |
Universtiy of Tuebingen | Recruiting |
Tuebingen, BW, Germany, 72076 | |
Contact: Gunnar Tepe, MD 49 7071 2983371 gunnar.tepe@med.uni-tuebingen.de | |
Sub-Investigator: Thomas Zeller, MD | |
Sub-Investigator: Dierk Scheinert, MD | |
Sub-Investigator: Marc Bosiers, MD | |
Sub-Investigator: Gerhard Rümenapf, MD | |
Sub-Investigator: Johannes Lammer, MD | |
Sub-Investigator: Ernst Pilger, MD | |
Sub-Investigator: Werner Jaschke, MD | |
Sub-Investigator: Dammis Vrougindeweij, MD |
Principal Investigator: | Gunnar Tepe, MD | University Hospital Tuebingen |
Study ID Numbers: | XXS |
Study First Received: | October 17, 2007 |
Last Updated: | October 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00546845 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration |