SOLARIS Endoprosthesis in Iliac Occlusive Disease

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

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-04-30

Brief Summary

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Fifty patients will be treated with Solaris Endoprosthesis and followed up to 2 years with Walking Impairment Questionnaire and Doppler Ultrasound evaluation in 30 days, 6 months and 12 months.

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Endoprosthesis implantation

Device implantation

Endoprosthesis implantation

Intervention Type DEVICE

Endoprosthesis implantation by Percutaneous Angioplasty

Interventions

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Endoprosthesis implantation

Endoprosthesis implantation by Percutaneous Angioplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Rutherford Class 2 to 5;
* Tasc II Class A, B, C or D;
* Unilateral or bilateral lesion, de novo or restenotic but not in-stent;
* Target lesion of 3 to 10 cm length;
* ≥ 50% stenosis or common iliac or external iliac artery;
* Reference vessel diameter ≥ 5 and ≤ 9 mm;
* Deep femoral artery patent and at least one infrapopliteal artery patent;
* Informed Consent provided.

Exclusion Criteria

* Thrombocytopenia induced by heparina or tPA intravenous, clopidogrel, ticlopidine or aspirin sensitivity;
* Target lesion near to aneurysm, highly calcified or excessively tortuous;
* Previous stent on target vessel;
* Presence of other lesions that need treatment within 30 days;
* Rutherford Class 6;
* Acute thrombotic occlusion;
* History on amputation on the target limb.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No