Stellarex Vascular E-Registry

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT02769273
• Lead Sponsor: Spectranetics Corporation

Brief Summary

Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Study Start: 2016-06
• Primary Completion: 2021-10-31
• Study Completion: 2021-12
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

• Patients intended to be treated with Stellarex for de-novo or restenotic lesions of the femoro-popliteal arteries
• Rutherford Clinical Category (RCC) 2-3 or 4 indicated for a Percutaneous Transluminal Angioplasty according to local applicable guidelines
• Age ≥18 years old
• Life expectancy > 1 year
• Is able and willing to provide written informed consent prior to enrollment in the study (as applicable)
• Is able and willing to come on site or to be contacted by phone for the follow-up

Exclusion Criteria

• Patients with any medical condition that would make him/her inappropriate for treatment with Stellarex as per Instructions for Use (IFU) or investigator's opinion
• Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints
• Patients that in the judgment of the investigator would need treatment below the knee before and/or during the index procedure.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	12 months post-procedure	Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and Clinically Driven Target Lesion Revascularization through 12 months post-procedure
Primary Efficacy Endpoint	12 months post-procedure	Freedom from Clinically Driven Target Lesion Revascularization

Trial Locations

Locations (46)

Medical University Graz; 🇦🇹 Graz, Austria

Krankenhaus der Barmherzigen Schwesterrn Reid; 🇦🇹 Ried im Innkreis, Austria

Krankenhaus Göttlicher Heiland GmbH; 🇦🇹 Vienna, Austria

OLV Aalst; 🇧🇪 Aalst, Belgium

Imelda; 🇧🇪 Bonheiden, Belgium

Europe Hospital; 🇧🇪 Brussels, Belgium

AZ Sint Blasius; 🇧🇪 Dendermond, Belgium

UZA Antwerpen; 🇧🇪 Edegem, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Jessa Ziekenhuis Hasselt; 🇧🇪 Hasselt, Belgium

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