Local Paclitaxel or Balloon Angioplasty Below the Knee

Stenosis Clinical Trial

— SAMBA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03149913
• Other study ID #: BTK 1
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2017
• Last updated: May 10, 2017
• Start date: December 15, 2016
• Est. completion date: July 2020

Study information

• Verified date: May 2017
• Source: Klinikum Rosenheim
• Contact: Gunnar Tepe, MD
• Phone: +498031365
• Email: gunnar.tepe[@]ro-med.de
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2020
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Occlusion
• Restenosis
• Stenosis

Intervention

Device:
• SequentPlease OTW paclitaxel coated balloon catheter
PTA with SequentPlease OTW paclitaxel coated balloon catheter
• conventional uncoated balloon for BTK endovascular therapy
PTA with uncoated balloon for BTK endovascular therapy

Locations

Country	Name	City	State
Austria	LKH-Univ. Klinikum Graz	Graz
Germany	Klinikum Arnsberg	Arnsberg
Germany	Herzzentrum Bad Krozingen	Bad Krozingen	BW
Germany	Ev.-Luth. Diakonissenanstalt zu Flensburg	Flensburg
Germany	Evangelisches Krankenhaus Mülheim a. d. Ruhr	Mülheim
Germany	Tepe	Rosenheim	BW
Germany	Universitätsklinikum Wu¨rzburg	Würzburg

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dr. med. Gunnar Tepe	InnoRa GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Walking distance	Evaluation of Rutherford category	3, 6, 12 and 24 months
Other	Wound status	improvement, no change, worsening	3, 6, 12 and 24 months
Primary	Occlusion rate of the target lesion at 6 months	by digital substraction angiogram or MRI	6 +/- 1 months
Secondary	target lesion revascularization	repeat intervention	3, 6, 12 and 24 months