Arteriosclerosis, Atherosclerosis, Claudication, Peripheral Artery Disease
Conditions
Keywords
drug-coated balloon, drug-eluting balloon, peripheral artery disease, claudication
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.
Interventions
DEVICERanger 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.
DEVICEuncoated PTA balloon
The index lesion is treated with one or more uncoated standard PTA balloons that completely cover the lesion.
Sponsors
CERES GmbH
coreLab Black Forest GmbH
Hemoteq AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
| primary patency | six months | Percentage of lesions that reach endpoint without a hemodynamically significant stenosis on duplex ultrasound (DUS) and without target lesion revascularization (TLR) or bypass of the target lesion to maintain or restore patency. |
| assisted primary patency | six months | Percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach endpoint without restenosis. |
| secondary patency | six months | Percentage of lesions with TLR for occlusion that reach endpoint without restenosis. |
| procedural success | within 24 hours of index procedure | Technical success with no MAE noted within 24 hours of the index procedure. |
| clinical success | pre-discharge, estim. 1-2 days post-index procedure | Positive change (by +1 or more) of Rutherford category at pre-discharge post-index-procedure as compared to baseline. |
| hemodynamic success | pre-discharge, estim. 1-2 days post-index procedure | positive change in Ankle-Brachial Index (ABI) at pre-discharge as compared to baseline |
| change in quality of life | six months | Change in functional status measured by changes in the Walking Impairment Questionnaire (WiQ) and general health-related quality of life measured by changes in SF-12 and EQ5D scores at six months (plus or minus 30 days) as compared to baseline. |
| binary restenosis rate | six 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. |
Countries
Austria, France, Germany
Outcome results
None listed