Clinical Trials Logo
  1. Home
  2. Stenosis
  3. NCT03149913

Local Paclitaxel or Balloon Angioplasty Below the Knee — SAMBA  

Stenosis Clinical Trial

Official title:
Does Local Paclitaxel Improve the Efficacy of Balloon Angioplasty Without Stent Implantation for Treatment of Below the Knee Artery Lesions?

Clinical Trial Summary

Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries

Clinical Trial Description

After successful guide wire passage of the below the knee index lesions the patients will either receive a treatment with a conventional uncoated balloon or a balloon coated with paclitaxel. Only patients who require follow-up angiography after 6 months will be included in this study. The primary endpoint (index vessel occluded or still open) is at 6 months - the patients will be also followed for 24 months for clinical endpoints. In addition an MRI is planned at 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03149913
Study type Interventional
Source Klinikum Rosenheim
Contact Gunnar Tepe, MD
Phone +498031365
Email gunnar.tepe@ro-med.de
Status Recruiting
Phase N/A
Start date December 15, 2016
Completion date July 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Recruiting NCT04584632 - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery N/A
Completed NCT02834806 - BIONICS Israel Trial N/A
Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
Withdrawn NCT00543348 - RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses N/A
Completed NCT00555659 - Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusions N/A
Completed NCT00205101 - Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Terminated NCT04370041 - Dokimos Plus Aortic Valve Implant in 80 Patients Diagnosed With a Heart Valve Disease and Requiring Valve Replacement N/A
Recruiting NCT05053932 - Long-term Comparative Cerebrovascular Outcome After Transplantation vs Standard Care in Sickle Cell Anemia
Completed NCT02373852 - PMS Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention
Completed NCT01970579 - Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter Phase 3
Completed NCT01873586 - OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion N/A
Completed NCT00540813 - Paclitaxel-Eluting Balloon Angioplasty and Coroflex™-Stents in the Treatment of Bifurcated Coronary Lesions N/A
Recruiting NCT00496639 - Stent vs. Angioplasty for Treatment of Thrombosed AV Grafts: Long-Term Outcomes N/A
Terminated NCT00254852 - Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft N/A
Enrolling by invitation NCT05583305 - Prevalence and Etiologies of Intracranial Stenosis in Patients With Antiphospholipid Syndrome
Completed NCT02018445 - Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion N/A
Withdrawn NCT03327272 - Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion Phase 3
Completed NCT04698512 - MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial
Active, not recruiting NCT02428582 - Covered Stents Versus Bare-Metal Stents N/A