Local Paclitaxel or Balloon Angioplasty Below the Knee (SAMBA)

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

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

Study Overview

• Status: Unknown
• Conditions: Restenosis; Occlusion; Stenosis
• Intervention / Treatment: Device: SequentPlease OTW paclitaxel coated balloon catheter; Device: conventional uncoated balloon for BTK endovascular therapy

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Not yet recruiting
    • Lkh-Univ. Klinikum Graz
    • Contact: M. Brodmann, MD
• Germany
  • Arnsberg, Germany
    • Not yet recruiting
    • Klinikum Arnsberg
    • Contact: M. Lichtenberg, MD
    • Principal Investigator: M Lichtenberg
  • Flensburg, Germany
    • Not yet recruiting
    • Ev.-Luth. Diakonissenanstalt zu Flensburg
    • Contact: S. Mueller-Huelsbeck, MD
  • Mülheim, Germany, 45468
    • Not yet recruiting
    • Evangelisches Krankenhaus Mülheim a. d. Ruhr
    • Contact: C. Nolte-Ernsting, MD
  • Würzburg, Germany
    • Not yet recruiting
    • Universitatsklinikum Wurzburg
    • Contact: R. Kickuth, MD
  • BW
    • Bad Krozingen, BW, Germany, 73000
      • Not yet recruiting
      • Herzzentrum Bad Krozingen
    • Rosenheim, BW, Germany, 83022
      • Recruiting
      • Tepe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• >18 years of age
• Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries
• Rutherford 2-5 patients
• Patients with ≤ 2 BTK lesions (≥ 70% diameter stenosis)
• Lesion length limited to 5-25 cm

Exclusion Criteria:

• Planned or foreseeable amputation
• Previous amputation at the index limb
• Index vessel with no run-off to the foot distal to the index lesion
• Prior treatment of the index lesion with a drug coated balloon
• In-stent restenosis
• Life expectancy <1 year
• Known creatinine >1.4 mg% if patient is not on dialysis
• Acute thrombus in the index limb
• Aneurysm in the index leg
• Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel
• Patients with concomitant medical illnesses that require cytostatic or radiation therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Drug coated balloon; SeQuentPlease OTW paclitaxel coated balloon catheter	Device: SequentPlease OTW paclitaxel coated balloon catheter; PTA with SequentPlease OTW paclitaxel coated balloon catheter
ACTIVE_COMPARATOR: uncoated PTA balloon catheter; Standard of care uncoated BTK balloon catheter	Device: conventional uncoated balloon for BTK endovascular therapy; PTA with uncoated balloon for BTK endovascular therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occlusion rate of the target lesion at 6 months	by digital substraction angiogram or MRI	6 +/- 1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
target lesion revascularization	repeat intervention	3, 6, 12 and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking distance	Evaluation of Rutherford category	3, 6, 12 and 24 months
Wound status	improvement, no change, worsening	3, 6, 12 and 24 months

Collaborators and Investigators

• Sponsor: Prof. Dr. med. Gunnar Tepe
• Collaborators: InnoRa GmbH

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2016
• Primary Completion (ANTICIPATED): December 30, 2018
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (ACTUAL): May 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: critical limb ischemia; endovascular; drug coated balloon; below the knee artery
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: BTK 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No