Clinical trial NCT02462005: Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.
Official title: Ranger DEB All Comers Registry - Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter: An All Comers Registry.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerotic Disease
Lead sponsor: Klinikum Arnsberg
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2015-06-03
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 and who fulfill the in/exclusion criteria at approved investigational centres are eligible for participation in the Ranger DEB-Comers Registry.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 6 Months
measure: Performance primary endpoint: Primary patency at 12 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention
timeFrame: 12 Months
Secondary outcomes:
measure: Primary patency at 6 and 24 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention
timeFrame: 6 and 24 Months
measure: MAE at 12 and 24 months
timeFrame: 12 and 24 Months
measure: Technical success, defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤ 50% residual stenosis (visual assessment)
timeFrame: Intraoperative
measure: Device success, defined as exact deployment of the device according to the IFU (operator assessment)
timeFrame: Intraoperative
measure: Procedural success, defined as the combination of technical success and device success
timeFrame: Intraoperative
measure: Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention)
timeFrame: 6, 12 and 24 months
measure: 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.
timeFrame: 6, 12 and 24 months
measure: Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 6, 12 and 24 months.
timeFrame: 6, 12 and 24 months
measure: Limb salvage, defined as preservation of the treated limb with no need for any amputation at 6, 12 and 24 months.
timeFrame: 6, 12 and 24 months
measure: Improvement of pain score at 6, 12 and 24 months compared to the pre-procedure score
timeFrame: 6, 12 and 24 months
Other outcomes:
Locations:
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland, Karolinen-Hospital
city: Bottrop
country: Germany
facility: Knappschaftskrankenhaus Bottrop
city: Karlsbad-Langensteinbach
country: Germany
facility: SRH Klinikum Karlsbad-Langensteinbach GmbH
city: Muenchen
country: Germany
facility: Gefaesspraxis im Tal
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
city: Lausanne
country: Switzerland
facility: CHUV, Service de Chirurgie Vasculaire
state: Vaud
Study officials:
References:
citation: Lichtenberg M, von Bilderling P, Ranft J, Niemoller K, Grell H, Briner L, Saucy F, Rassaf T, Breuckmann F. Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry. J Cardiovasc Surg (Torino). 2018 Feb;59(1):45-50. doi: 10.23736/S0021-9509.17.10261-2. Epub 2017 Oct 3.