Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries (RANGER-SFA)

Hemoteq

Status

Completed

Conditions

Claudication

Peripheral Artery Disease

Arteriosclerosis

Atherosclerosis

Treatments

Device: Ranger DCB

Device: uncoated PTA balloon

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02013193

HTQ001-RangerSFA

CIV-13-07-011514 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)