Overview

This trial is active, not recruiting.

Conditions peripheral artery disease, claudication, atherosclerosis, arteriosclerosis
Treatments ranger dcb, uncoated pta balloon
Sponsor Hemoteq AG
Collaborator CERES GmbH
Start date January 2014
End date May 2016
Trial size 105 participants
Trial identifier NCT02013193, CIV-13-07-011514, HTQ001-RangerSFA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Index lesion treated with Ranger(TM) Paclitaxel-coated PTA balloon catheter (Ranger DCB)
ranger dcb
After successful pre-dilatation the index lesion is treated with one or two Ranger DCB devices that completely cover the lesion. If two devices are deployed, overlap shall be minimal.
(Active Comparator)
Index lesion treated with an uncoated standard PTA dilatation balloon catheter selected upon investigator´s discretion
uncoated pta balloon
The index lesion is treated with one or more uncoated standard PTA balloons that completely cover the lesion.

Primary Outcomes

Measure
in-segment late lumen loss
time frame: six months

Secondary Outcomes

Measure
technical success
time frame: during index procedure, less 1 hour
procedural success
time frame: within 24 hours of index procedure
primary patency
time frame: six months
primary patency
time frame: twelve months
assisted primary patency
time frame: six months
assisted primary patency
time frame: twelve months
secondary patency
time frame: six months
secondary patency
time frame: twelve months
binary restenosis rate
time frame: six months
binary restenosis rate
time frame: twelve months
clinical success
time frame: pre-discharge, estim. 1-2 days post-index procedure
clinical success
time frame: six months
clinical success
time frame: twelve months
hemodynamic success
time frame: pre-discharge, estim. 1-2 days post-index procedure
hemodynamic success
time frame: six months
hemodynamic success
time frame: twelve months
change in quality of life
time frame: six months
change in quality of life
time frame: twelve months
change in quality of life
time frame: 24 months
change in quality of life
time frame: 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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
Principal investigator Dierk Scheinert, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Hemoteq AG.