Stellarex Vascular E-Registry

Spectranetics Corporation1,900 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,900

Conditions

Peripheral Arterial Disease

Interventions

Percutaneous Transluminal AngioplastyDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (46)

Outcomes

Primary Outcomes

Primary Efficacy Endpoint Cohort 1 - RCC 2-3:

Freedom from clinically-driven Target Lesion Revascularization (CD-TLR) at 12 months post- procedure.

Time frame: 12 months post-procedure

Primary Safety Endpoint-Cohort 1 - RCC 2-3

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.

Time frame: 30 days post-procedure - 12Month post procedure

Primary effectiveness endpoint: Cohort 2 - RCC 4-6 (CLI)

Freedom from CD-TLR at 6 months post-procedure.

Time frame: 6 Months post procedure

Primary safety endpoint-Cohort 2 - RCC 4-6 (CLI)

Freedom from Composite MALE and POD through 30 days

Time frame: 30days

Secondary Outcomes

Rate and Freedom from events as specified in the description :Cohort 1 - RCC 2-3

* 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

Time frame: as specified in the description

Rate and Freedom-from-Cohort 2 - RCC 4-6

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

Data from ClinicalTrials.gov

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Medical University Graz

Graz, Austria

Krankenhaus der Barmherzigen Schwesterrn Reid

Ried im Innkreis, Austria

Krankenhaus Göttlicher Heiland GmbH

Vienna, Austria

UZA Antwerpen

Edegem, Edegem, Belgium

OLV Aalst

Aalst, Belgium

Imelda

Bonheiden, Belgium

Europe Hospital

Brussels, Belgium

AZ Sint Blasius

Dendermonde, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Jessa Ziekenhuis Hasselt

Hasselt, Belgium

...and 36 more locations