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

Not Applicable

Completed

• Conditions: Peripheral Artery Disease; Claudication; Atherosclerosis; Arteriosclerosis
• Interventions: Device: Ranger DCB; Device: uncoated PTA balloon

• Registration Number: NCT02013193
• Lead Sponsor: Hemoteq AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-17
• Study Start: 2014-01-07
• Primary Completion: 2016-06-16
• Study Completion: 2019-03-15
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranger(TM) Paclitaxel-coated balloon	Ranger DCB	Index lesion treated with Ranger(TM) Paclitaxel-coated PTA balloon catheter (Ranger DCB)
uncoated PTA balloon	uncoated PTA balloon	Index lesion treated with an uncoated standard PTA dilatation balloon catheter selected upon investigator´s discretion

Primary Outcome Measures

Name	Time	Method
in-segment late lumen loss	six months	In-segment late lumen loss (LLL) of the treated segment after PTA using the Ranger™ paclitaxel-coated PTA balloon, in comparison to the LLL after PTA using an uncoated balloon, as observed by angiography at six months post-index procedure.

Secondary Outcome Measures

Name	Time	Method
procedural success	within 24 hours of index procedure	Technical success with no MAE noted within 24 hours of the index procedure.
assisted primary patency	twelve months	Percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach endpoint without restenosis.
secondary patency	twelve months	Percentage of lesions with TLR for occlusion that reach endpoint without restenosis.
primary patency	twelve months	Percentage of lesions that reach endpoint without a hemodynamically significant stenosis on DUS and without TLR or bypass of the target lesion to maintain or restore patency.
clinical success	twelve months	Positive change (by +1 or more) of Rutherford category at twelve months (plus or minus 30 days) post-index-procedure as compared to baseline.
hemodynamic success	twelve months	positive change in ABI at twelve months (plus or minus 30 days) as compared to baseline
technical success	during index procedure, less 1 hour	The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.
binary restenosis rate	twelve months	Binary restenosis defined as \> 50% diameter stenosis via peak systolic velocity ratio (PSVR) \> 2.4 via duplex ultrasound and assessed by the core lab.
change in quality of life	36 months	Change in general health-related quality of life measured by changes in SF-12 and EQ5D scores at 36 months (plus or minus 30 days) as compared to baseline.

Trial Locations

Locations (11)

Medical University, AKH; 🇦🇹 Vienna, Austria

CHU Caen Côte de Nacre; 🇫🇷 Caen, France

Clinique Pasteur Toulouse; 🇫🇷 Toulouse, France

Hopital Europeen Georges-Pompidou (HEGP); 🇫🇷 Paris, France

Klinikum Arnsberg; 🇩🇪 Arnsberg, Germany

Segeberger Kliniken; 🇩🇪 Bad Segeberg, Germany

Klinikum Darmstadt GmbH; 🇩🇪 Darmstadt, Germany

CardioVascular Center; 🇩🇪 Frankfurt, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Park-Krankenhaus; 🇩🇪 Leipzig, Germany

Universitätsklinikum; 🇩🇪 Marburg, Germany