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Peripheral Artery DiseaseRANGER-SFANCT02013193

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

A study testing Ranger DCB and uncoated PTA balloon in people with Peripheral Artery Disease and Claudication, run by Hemoteq AG at 11 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ranger DCB and uncoated PTA balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
11 sitesin 3 countries
Study dates
7 Jan 2014to 15 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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)

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

Germany7 sites

  • Klinikum Arnsberg

    Arnsberg, 59759

  • Segeberger Kliniken

    Bad Segeberg, 23795

  • Klinikum Darmstadt GmbH

    Darmstadt, 64283

  • CardioVascular Center

    Frankfurt, 60389

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Park-Krankenhaus

    Leipzig, 04289

  • Universitätsklinikum

    Marburg, 35043

Other trials in Germany

France3 sites

  • CHU Caen Côte de Nacre

    Caen, 14000

  • Hopital Europeen Georges-Pompidou (HEGP)

    Paris, 75908

  • Clinique Pasteur Toulouse

    Toulouse, 31076

Other trials in France

Austria1 site

  • Medical University, AKH

    Vienna, 1090

Other trials in Austria

About this study

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

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.

Being tested
Ranger DCB, uncoated PTA balloon
Keywords
drug-coated balloon, drug-eluting balloon, peripheral artery disease, claudication
Medical subject headings
Peripheral Arterial Disease, Intermittent Claudication, Atherosclerosis, Arteriosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ranger DCBDevice

    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.

  • uncoated PTA balloonDevice

    The index lesion is treated with one or more uncoated standard PTA balloons that completely cover the lesion.

Study groups in NCT02013193
Study groupRoleWhat they receive
Ranger(TM) Paclitaxel-coated balloonExperimentalIndex lesion treated with Ranger(TM) Paclitaxel-coated PTA balloon catheter (Ranger DCB)
Receives: Device: Ranger DCB
uncoated PTA balloonActive comparatorIndex lesion treated with an uncoated standard PTA dilatation balloon catheter selected upon investigator´s discretion
Receives: Device: uncoated PTA balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. in-segment late lumen loss

    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.

    Measured: six months

Secondary outcomes (20)

  1. technical success

    The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.

    Measured: during index procedure, less 1 hour

  2. procedural success

    Technical success with no MAE noted within 24 hours of the index procedure.

    Measured: within 24 hours of index procedure

  3. primary patency

    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.

    Measured: six months

  4. primary patency

    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.

    Measured: twelve months

  5. assisted primary patency

    Percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach endpoint without restenosis.

    Measured: six months

  6. assisted primary patency

    Percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach endpoint without restenosis.

    Measured: twelve months

  7. secondary patency

    Percentage of lesions with TLR for occlusion that reach endpoint without restenosis.

    Measured: six months

  8. secondary patency

    Percentage of lesions with TLR for occlusion that reach endpoint without restenosis.

    Measured: twelve months

  9. binary restenosis rate

    Binary restenosis defined as > 50% diameter stenosis via peak systolic velocity ratio (PSVR) > 2.4 via duplex ultrasound and assessed by the core lab.

    Measured: six months

  10. binary restenosis rate

    Binary restenosis defined as > 50% diameter stenosis via peak systolic velocity ratio (PSVR) > 2.4 via duplex ultrasound and assessed by the core lab.

    Measured: twelve months

  11. clinical success

    Positive change (by +1 or more) of Rutherford category at pre-discharge post-index-procedure as compared to baseline.

    Measured: pre-discharge, estim. 1-2 days post-index procedure

  12. clinical success

    Positive change (by +1 or more) of Rutherford category at six months (plus or minus 30 days) post-index-procedure as compared to baseline.

    Measured: six months

  13. clinical success

    Positive change (by +1 or more) of Rutherford category at twelve months (plus or minus 30 days) post-index-procedure as compared to baseline.

    Measured: twelve months

  14. hemodynamic success

    positive change in Ankle-Brachial Index (ABI) at pre-discharge as compared to baseline

    Measured: pre-discharge, estim. 1-2 days post-index procedure

  15. hemodynamic success

    positive change in ABI at six months (plus or minus 30 days) as compared to baseline

    Measured: six months

  16. hemodynamic success

    positive change in ABI at twelve months (plus or minus 30 days) as compared to baseline

    Measured: twelve months

  17. change in quality of life

    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.

    Measured: six months

  18. change in quality of life

    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.

    Measured: twelve months

  19. change in quality of life

    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.

    Measured: 24 months

  20. change in quality of life

    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.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2013 (estimated)
  2. Study start7 Jan 2014
  3. Primary completion16 Jun 2016
  4. Study completion15 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02013193
Sponsor's protocol ID
HTQ001-RangerSFA
Other IDs
CIV-13-07-011514
Acronym
RANGER-SFA
Status last verified
Dec 2019
First submitted
11 Dec 2013
Last updated
23 Dec 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Bausback Y, Willfort-Ehringer A, Sievert H, Geist V, Lichtenberg M, Del Giudice C, Sauguet A, Diaz-Cartelle J, Marx C, Strobel A, Schult I, Scheinert D; RANGER SFA Investigators. Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment. J Endovasc Ther. 2017 Aug;24(4):459-467. doi: 10.1177/1526602817710770. Epub 2017 May 31.

    PubMed 28558502

Questions about this trial

What is this clinical trial studying?

A study testing Ranger DCB and uncoated PTA balloon in people with Peripheral Artery Disease and Claudication, run by Hemoteq AG at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany, France, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

in-segment late lumen loss (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02013193, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.

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