Local Paclitaxel or Balloon Angioplasty Below the Knee

NCT03149913 | Unknown

• 1 other identifier: BTK 1
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 7

Brief 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

Conditions

Stenosis; Occlusion; Restenosis

Keywords

below the knee artery; endovascular; drug coated balloon; critical limb ischemia

Outcome Measures

Primary Outcomes (1)

• Occlusion rate of the target lesion at 6 months

  by digital substraction angiogram or MRI

  6 +/- 1 months

Secondary Outcomes (1)

• target lesion revascularization

  3, 6, 12 and 24 months

Other Outcomes (2)

• Walking distance

  3, 6, 12 and 24 months

• Wound status

  3, 6, 12 and 24 months

Study Arms (2)

Drug coated balloon

EXPERIMENTAL

SeQuentPlease OTW paclitaxel coated balloon catheter

Device: SequentPlease OTW paclitaxel coated balloon catheter

uncoated PTA balloon catheter

ACTIVE COMPARATOR

Standard of care uncoated BTK balloon catheter

Device: conventional uncoated balloon for BTK endovascular therapy

Interventions

SequentPlease OTW paclitaxel coated balloon catheter DEVICE

PTA with SequentPlease OTW paclitaxel coated balloon catheter

Drug coated balloon

conventional uncoated balloon for BTK endovascular therapy DEVICE

PTA with uncoated balloon for BTK endovascular therapy

uncoated PTA balloon catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. med. Gunnar Tepe: lead
• InnoRa GmbH: collaborator

Study Sites (7)

LKH-Univ. Klinikum Graz

Graz, Austria

NOT YET RECRUITING

Herzzentrum Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, 73000, Germany

NOT YET RECRUITING

Tepe

Rosenheim, Baden-Wurttemberg, 83022, Germany

RECRUITING

Klinikum Arnsberg

Arnsberg, Germany

NOT YET RECRUITING

Ev.-Luth. Diakonissenanstalt zu Flensburg

Flensburg, Germany

NOT YET RECRUITING

Evangelisches Krankenhaus Mülheim a. d. Ruhr

Mülheim, 45468, Germany

NOT YET RECRUITING

Universitätsklinikum Würzburg

Würzburg, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Constriction, Pathologic; Bites and Stings; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia

Study Officials

• Gunnar Tepe, MD

  RoMed Klinikum Rosenheim

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gunnar Tepe, MD

CONTACT

+498031365; gunnar.tepe@ro-med.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: drug coated balloon versus uncoated balloon
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Deparment of Radiology, Clinical Professor

Model Details: The vessel patency (measured by angiography at 6 months) will be compared after patients have been treated either with paclitaxel coated or uncoated balloons (control) in BTK arteries

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: May 11, 2017
• Study Start: December 15, 2016
• Primary Completion: December 30, 2018
• Study Completion: July 1, 2020
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

AU (1); DE (6)