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

Hemoteq AG11 sites in 3 countries105 target enrollmentJanuary 7, 2014

ConditionsPeripheral Artery Disease Claudication Atherosclerosis Arteriosclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: Hemoteq AG
Enrollment: 105
Locations: 11
Primary Endpoint: in-segment late lumen loss
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 7, 2014

End Date

March 15, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hemoteq AG

Responsible Party

Sponsor

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

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

Outcomes

Primary Outcomes

in-segment late lumen loss

Time Frame: 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.