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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Hemoteq AG
Sponsor:
Collaborators:
Ceres GmbH evaluation & research
CoreLab Bad Krozingen GmbH
Information provided by (Responsible Party):
Hemoteq AG
ClinicalTrials.gov Identifier:
NCT02013193
First received: December 11, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Peripheral Artery Disease
Claudication
Atherosclerosis
Arteriosclerosis
Device: Ranger DCB
Device: uncoated PTA balloon

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hemoteq AG:

Primary Outcome Measures:
  • in-segment late lumen loss [ Time Frame: six months ] [ Designated as safety issue: No ]
    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:
  • technical success [ Time Frame: during index procedure, less 1 hour ] [ Designated as safety issue: No ]
    The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.

  • procedural success [ Time Frame: within 24 hours of index procedure ] [ Designated as safety issue: Yes ]
    Technical success with no MAE noted within 24 hours of the index procedure.

  • primary patency [ Time Frame: six months ] [ Designated as safety issue: No ]
    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.

  • primary patency [ Time Frame: twelve months ] [ Designated as safety issue: No ]
    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.

  • assisted primary patency [ Time Frame: six months ] [ Designated as safety issue: No ]
    Percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach endpoint without restenosis.

  • assisted primary patency [ Time Frame: twelve months ] [ Designated as safety issue: No ]
    Percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach endpoint without restenosis.

  • secondary patency [ Time Frame: six months ] [ Designated as safety issue: No ]
    Percentage of lesions with TLR for occlusion that reach endpoint without restenosis.

  • secondary patency [ Time Frame: twelve months ] [ Designated as safety issue: No ]
    Percentage of lesions with TLR for occlusion that reach endpoint without restenosis.

  • binary restenosis rate [ Time Frame: six months ] [ Designated as safety issue: No ]
    Binary restenosis defined as > 50% diameter stenosis via peak systolic velocity ratio (PSVR) > 2.4 via duplex ultrasound and assessed by the core lab.

  • clinical success [ Time Frame: pre-discharge, estim. 1-2 days post-index procedure ] [ Designated as safety issue: No ]
    Positive change (by +1 or more) of Rutherford category at pre-discharge post-index-procedure as compared to baseline.

  • clinical success [ Time Frame: six months ] [ Designated as safety issue: No ]
    Positive change (by +1 or more) of Rutherford category at six months (plus or minus 30 days) post-index-procedure as compared to baseline.

  • clinical success [ Time Frame: twelve months ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-discharge, estim. 1-2 days post-index procedure ] [ Designated as safety issue: No ]
    positive change in Ankle-Brachial Index (ABI) at pre-discharge as compared to baseline

  • hemodynamic success [ Time Frame: six months ] [ Designated as safety issue: No ]
    positive change in ABI at six months (plus or minus 30 days) as compared to baseline

  • hemodynamic success [ Time Frame: twelve months ] [ Designated as safety issue: No ]
    positive change in ABI at twelve months (plus or minus 30 days) as compared to baseline

  • change in quality of life [ Time Frame: six months ] [ Designated as safety issue: No ]
    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.

  • change in quality of life [ Time Frame: twelve months ] [ Designated as safety issue: No ]
    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 twelve months (plus or minus 30 days) as compared to baseline.

  • change in quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Change in general health-related quality of life measured by changes in SF-12 and EQ5D scores at 24 months (plus or minus 30 days) as compared to baseline.

  • change in quality of life [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 105
Study Start Date: January 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranger(TM) Paclitaxel-coated balloon
Index lesion treated with Ranger(TM) Paclitaxel-coated PTA balloon catheter (Ranger DCB)
Device: 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: uncoated PTA balloon
Index lesion treated with an uncoated standard PTA dilatation balloon catheter selected upon investigator´s discretion
Device: uncoated PTA balloon
The index lesion is treated with one or more uncoated standard PTA balloons that completely cover the lesion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013193

Locations
Austria
Landeskrankenhaus Withdrawn
Feldkirch, Vorarlberg, Austria, 6800
Medical University, AKH Recruiting
Vienna, Austria, 1090
Contact: Andrea Willfort-Ehringer, MD       andrea.willfort-ehringer@meduniwien.ac.at   
Principal Investigator: Andrea Willfort-Ehringer, MD         
Germany
Klinikum Arnsberg Recruiting
Arnsberg, Germany, 59759
Contact: Michael Lichtenberg, MD       m.lichtenberg@klinikum-arnsberg.de   
Principal Investigator: Michael Lichtenberg, MD         
Segeberger Kliniken Recruiting
Bad Segeberg, Germany, 23795
Contact: Volker Geist, MD       volker.geist@segebergerkliniken.de   
Principal Investigator: Volker Geist, MD         
Klinikum Darmstadt GmbH Recruiting
Darmstadt, Germany, 64283
Contact: Peter Huppert, MD       huppert@klinikum-darmstadt.de   
Principal Investigator: Peter Huppert, MD         
CardioVascular Center Recruiting
Frankfurt, Germany, 60389
Contact: Horst Sievert, MD       info@cvcfrankfurt.de   
Principal Investigator: Horst Sievert, MD         
Park-Krankenhaus Active, not recruiting
Leipzig, Germany, 04289
Sponsors and Collaborators
Hemoteq AG
Ceres GmbH evaluation & research
CoreLab Bad Krozingen GmbH
Investigators
Principal Investigator: Dierk Scheinert, M.D. Park-Krankenhaus Leipzig GmbH
  More Information

No publications provided

Responsible Party: Hemoteq AG
ClinicalTrials.gov Identifier: NCT02013193     History of Changes
Other Study ID Numbers: HTQ001-RangerSFA, CIV-13-07-011514
Study First Received: December 11, 2013
Last Updated: September 8, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Austrian Medicines and Medical Devices Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hemoteq AG:
drug-coated balloon
drug-eluting balloon
peripheral artery disease
claudication

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Peripheral Arterial Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014