Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment

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

COMPLETED

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-10-31

Brief Summary

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The aim of this observational study is to evaluate the outcomes and safety of the Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease (PAD) in below-the-knee vessels

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Detailed Description

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The management of critical limb ischemia due to below-the-knee disease remains challenging due to the frequent patient comorbidities, diffuse vascular involvement, limb preservation, and high rates of restenosis and disease progression. This study will record the use of ELUTAX SV-DEB under real life conditions in a representative sample.The investigators will generate new data in observing the outcome and the safety of the Elutax SV drug-eluting balloons for change in Rutherford clinical category from baseline to 6 and 12 month follow-up visits.

Conditions

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Critical Limb Ischemia Peripheral Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with critical limb ischemia

Patients undergoing endovascular intervention of below-the-knee arteries with ELUTAX SV DEB (drug-eluting balloon).

Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV

Intervention Type DEVICE

Angioplasty for revascularization in below-the-knee arteries

Interventions

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Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV

Angioplasty for revascularization in below-the-knee arteries

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Paclitaxel-eluting balloon angioplasty in below-the-knee lesions with ELUTAX SV-DEB
* Age ≥ 18 years
* Signed informed consent
* documented Critical Limb Ischemia (CLI) in the target limb prior to the study
* Rutherford Category 4, 5 or 6
* ≥70% diameter stenosis or occlusion in the target lesion, including de-novo / in-stent restenosis/occlusion of target lesion
* Patent inflow artery
* Target vessel(s) diameter between 2 and 4 mm
* Target vessel(s) reconstitute(s) at or above the ankle

Exclusion Criteria

* Life expectancy below 50% within the next 12 months (as judged by the investigator)
* Planned major index limb amputation
* Acute limb ischemia (within last 14 days thrombectomy, atherectomy, or lysis)
* Application of DEB-eluting balloons except from ELUTAX SV in the same target limb (POBA is allowed)
* Patient unwilling or unlikely to comply with follow-up schedule

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No