Local Paclitaxel or Balloon Angioplasty Below the Knee

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-15

Study Completion Date

2020-07-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Stenosis Occlusion Restenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

drug coated balloon versus uncoated balloon

Study Groups

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Drug coated balloon

SeQuentPlease OTW paclitaxel coated balloon catheter

Group Type EXPERIMENTAL

SequentPlease OTW paclitaxel coated balloon catheter

Intervention Type DEVICE

PTA with SequentPlease OTW paclitaxel coated balloon catheter

uncoated PTA balloon catheter

Standard of care uncoated BTK balloon catheter

Group Type ACTIVE_COMPARATOR

conventional uncoated balloon for BTK endovascular therapy

Intervention Type DEVICE

PTA with uncoated balloon for BTK endovascular therapy

Interventions

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SequentPlease OTW paclitaxel coated balloon catheter

PTA with SequentPlease OTW paclitaxel coated balloon catheter

Intervention Type DEVICE

conventional uncoated balloon for BTK endovascular therapy

PTA with uncoated balloon for BTK endovascular therapy

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Prof. Dr. med. Gunnar Tepe

Director of the Deparment of Radiology, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gunnar Tepe, MD

Role: PRINCIPAL_INVESTIGATOR

RoMed Klinikum Rosenheim

Locations

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