Clinical trial NCT02013193: Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries
Official title: Prospective, Randomized, Multicentre Clinical Study of the Hemoteq Ranger™ Paclitaxel-Coated PTA Balloon Catheter (Ranger DCB) in Comparison to Uncoated PTA Balloons in Femoropopliteal Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Claudication
Atherosclerosis
Arteriosclerosis
Keywords: drug-coated balloon
drug-eluting balloon
peripheral artery disease
claudication
Lead sponsor: Hemoteq AG
Sponsor class: INDUSTRY
Collaborators: name: CERES GmbH
name: coreLab Black Forest GmbH
First posted: 2013-12-17
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months post-procedure when comparing Late Lumen Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger DCB study devices is lower than the %-mean loss of luminal diameter after treatment with uncoated PTA balloon control devices.


Eligibility criteria: Inclusion Criteria:

* Subjects must be age 18 or older
* Subject is willing and able to provide informed consent
* Subject is available to attend all required follow-up visits
* Subject has a clinically significant symptomatic leg ischemia requiring treatment
* Subject has a Rutherford clinical category of 2-4
* If the index lesion is restenotic, the prior PTA must have been \>30 days prior to treatment in the current study
* Only one lesion per limb can be treated under this protocol.
* Successful intraluminal wire crossing of the target lesion
* Index lesion is a clinically and hemodynamically significant stenotic or restenotic lesion located in the native nonstented superficial femoral artery or proximal popliteal artery
* Degree of stenosis 70% or more, by visual assessment
* Lesion length between 20 mm and 150 mm
* At least one patent infrapopliteal artery to the foot of the index limb

Exclusion Criteria:

* Subjects who have undergone prior vascular surgery of the femoropopliteal artery in the index limb to treat atherosclerotic disease
* History of major amputation in the same limb as the target lesion
* Presence of aneurysm in the target vessel
* Acute ischemia and/or acute thrombosis in any artery of the lower limbs
* Acute Myocardial Infarction within 30 days before the index procedure
* Persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy
* Known hypersensitivity or contraindication to contrast dye that cannot be adequately pre-medicated
* Known allergies against Paclitaxel or other components of the used medical devices
* Intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would be administered during the trial
* Platelet count \<100,000 mm3 or \>600,000 mm3
* Concomitant renal failure with a serum creatinine \>2.0 mg/dL
* Receiving dialysis or immunosuppressant therapy
* Life expectancy of less than one year
* Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.
* Woman who is pregnant or nursing.
* Previously planned stenting of the index lesion
* Use of adjunctive therapies (debulking, laser, cryoplasty, re-entry devices)
* Planned or expected procedures (cardiac, aorta, peripheral) within 30 days after the index procedure
* Presence of outflow lesions requiring intervention within 30 days of the index procedure
* Perforated vessel as evidenced by extravasation of contrast media
* Heavily calcified target lesions resistant to PTA
* Current participation in another drug or device trial that has not completed the primary endpoint, that may potentially confound the results of this trial, or that would limit the subject's compliance with the follow-up requirements
* Current participation in any study using drug-coated/drug-eluting technologies
* Current participation in any study using drug-coated/drug-eluting technologies
* Target lesion with in-stent restenosis (any stent or stent-graft)

Primary outcomes:
measure: in-segment late lumen loss
timeFrame: six months
Secondary outcomes:
measure: technical success
timeFrame: during index procedure, less 1 hour
measure: procedural success
timeFrame: within 24 hours of index procedure
measure: primary patency
timeFrame: six months
measure: primary patency
timeFrame: twelve months
measure: assisted primary patency
timeFrame: six months
measure: assisted primary patency
timeFrame: twelve months
measure: secondary patency
timeFrame: six months
measure: secondary patency
timeFrame: twelve months
measure: binary restenosis rate
timeFrame: six months
measure: binary restenosis rate
timeFrame: twelve months
measure: clinical success
timeFrame: pre-discharge, estim. 1-2 days post-index procedure
measure: clinical success
timeFrame: six months
measure: clinical success
timeFrame: twelve months
measure: hemodynamic success
timeFrame: pre-discharge, estim. 1-2 days post-index procedure
measure: hemodynamic success
timeFrame: six months
measure: hemodynamic success
timeFrame: twelve months
measure: change in quality of life
timeFrame: six months
measure: change in quality of life
timeFrame: twelve months
measure: change in quality of life
timeFrame: 24 months
measure: change in quality of life
timeFrame: 36 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University, AKH
city: Caen
country: France
facility: CHU Caen Côte de Nacre
city: Paris
country: France
facility: Hopital Europeen Georges-Pompidou (HEGP)
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
city: Arnsberg
country: Germany
facility: Klinikum Arnsberg
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH
city: Frankfurt
country: Germany
facility: CardioVascular Center
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Leipzig
country: Germany
facility: Park-Krankenhaus
city: Marburg
country: Germany
facility: Universitätsklinikum
Study officials:
affiliation: University Leipzig
name: Dierk Scheinert, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bausback Y, Willfort-Ehringer A, Sievert H, Geist V, Lichtenberg M, Del Giudice C, Sauguet A, Diaz-Cartelle J, Marx C, Strobel A, Schult I, Scheinert D; RANGER SFA Investigators. Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment. J Endovasc Ther. 2017 Aug;24(4):459-467. doi: 10.1177/1526602817710770. Epub 2017 May 31.