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: 2016-06-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-13
• Last Update Posted: 2025-08-14

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
• Patients intended to be treated with Stellarex for de-novo or restenotic lesions of the superficial femoral, popliteal and/or infra-popliteal arteries*
• Rutherford Clinical Category (RCC) 2-6 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 with severe disease of foot circulation defined as:

  • "desert foot" (absence of any angiographically visible arterial network below the ankle)
  • Or lack of a patent (<50%DS) and hemodynamically relevant wound related arterial pathway in the foot

• Patients confined to bed that are completely non ambulatory

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint Cohort 1 - RCC 2-3:	12 months post-procedure	Freedom from clinically-driven Target Lesion Revascularization (CD-TLR) at 12 months post- procedure.
Primary Safety Endpoint-Cohort 1 - RCC 2-3	30 days post-procedure - 12Month post procedure	Freedom from device and procedure- related death through 30 days post-procedure and freedom from target limb major amputation and CD-TLR through 12 months post-procedure.
Primary effectiveness endpoint: Cohort 2 - RCC 4-6 (CLI)	6 Months post procedure	Freedom from CD-TLR at 6 months post-procedure.
Primary safety endpoint-Cohort 2 - RCC 4-6 (CLI)	30days	Freedom from Composite MALE and POD through 30 days

Secondary Outcome Measures

Name	Time	Method
Rate and Freedom from events as specified in the description :Cohort 1 - RCC 2-3	as specified in the description	* All-cause mortality at 12, 24 and 36 months post- procedure; * Cardiovascular death at 12, 24, 36 months post- procedure; * Procedural complication defined as occurrence of death, stroke, myocardial infraction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure; * Device or procedure related death at 30 days; * Major target limb amputation at 12, 24, 36 months post-procedure; * CD-TLR through 12 (rate only), 24 and 36 months; * Clinically Driven- Target Vessel Revascularization (CD- TVR) through 12, 24 and 36 months
Rate and Freedom-from-Cohort 2 - RCC 4-6	As specified in the description	All-cause mortality at 6, 12, 24 and 36 months post- procedure; * Cardiovascular death at 6, 12, 24, 36 months post- procedure; * Procedural complication defined as occurrence of death, stroke, myocardial infraction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure; * Device or procedure related death at 30 days o Major target limb amputation at 6, 12, 24, 36 months post-procedure; * CD-TLR through 6 (rate only), 12, 24 and 36 months o Clinically Driven- Target Vessel Revascularization (CD- TVR) through 6, 12, 24 and 36 months; * Wound healing rate through 6, 12, 24, and 36 months post-procedure; * Minor amputation through 6, 12, 24 and 36 months; * Amputation-free survival through 6, 12, 24 and 36 months

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; 🇧🇪 Dendermonde, Belgium

UZA Antwerpen; 🇧🇪 Edegem, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Jessa Ziekenhuis Hasselt; 🇧🇪 Hasselt, Belgium

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