Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.

N/ACompletedNCT02462005

Klinikum Arnsberg171 enrolled

Overview

A total of up to 250 patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon. Interim analysis will be carried out for every 50 subjects enrolled.

Study Type

OBSERVATIONAL

Enrollment

171

Conditions

Atherosclerotic Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years. * Patient must be willing to sign a a patient informed consent form. * Patient with de novo, restenotic or reoccluded lesions in the infrainguinal .arteries implanted or scheduled for an implant with a Ranger Drug coated balloon. * Target vessel reference diameter 2.5 to 8 mm. Exclusion Criteria: * Subjects pregnant or planning to become pregnant during the course of the study. * Life expectancy of less than 1 year. * Known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications. Subject enrolled in another study that has not reached its primary endpoint at the time of enrolment.

Locations (6)

Klinikum Hochsauerland, Karolinen-Hospital

Arnsberg, Germany

Knappschaftskrankenhaus Bottrop

Bottrop, Germany

SRH Klinikum Karlsbad-Langensteinbach GmbH

Karlsbad-Langensteinbach, Germany

Gefaesspraxis im Tal

München, Germany

Outcomes

Primary Outcomes

Clinical primary endpoint: Major Adverse Events (MAE) defined as composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 6 months post-index procedure.

Time frame: 6 Months

Performance primary endpoint: Primary patency at 12 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention

Time frame: 12 Months

Secondary Outcomes

Primary patency at 6 and 24 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention

Time frame: 6 and 24 Months

MAE at 12 and 24 months

Time frame: 12 and 24 Months

Technical success, defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤ 50% residual stenosis (visual assessment)

Time frame: Intraoperative

Device success, defined as exact deployment of the device according to the IFU (operator assessment)

Time frame: Intraoperative

Procedural success, defined as the combination of technical success and device success

Time frame: Intraoperative

Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention)

Time frame: 6, 12 and 24 months

Improvement of at least one Rutherford class at 6, 12 and 24 months (an prior to any reintervention) compared to the pre-procedure Rutherford classification.

Data from ClinicalTrials.gov

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