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Peripheral Artery DiseaseNCT02701543

Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease

A study testing Ranger Drug Eluting Balloon and In Pact Drug Eluting Balloon in people with Peripheral Artery Disease, run by University of Leipzig at 1 site in Germany.

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

To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal Artery in Peripheral Artery Disease (PAD) patients with Rutherford class 2-4. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Artery Disease
What is being tested?
Ranger Drug Eluting Balloon and In Pact Drug Eluting Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
414 participants
Where
1 siteGermany
Study dates
Oct 2015to Dec 2023
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

  • Subject age ≥ 18
  • Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing Rutherford category 2-4.
  • Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
  • Target lesion length is ≤ 30cm
  • Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
  • Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 30 cm.
Show all 9Show fewer
  • Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.
  • Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery.
  • A guidewire has successfully traversed the target treatment segment.

Who cannot join

  • Failure to successfully cross the target lesion
  • Angiographic evidence of severe calcification
  • Presence of fresh thrombus in the lesion.
  • Presence of aneurysm in the target vessel/s
  • Presence of a stent in the target lesion
  • Prior vascular surgery of the target lesion.
Show all 14Show fewer
  • Stroke or heart attack within 3 months prior to enrollment
  • Any surgical procedure or intervention performed within 30 days prior to or post index procedure
  • Superficial femoropopliteal Artery or Proximal popliteal artery disease in the opposite leg that requires treatment at the index procedure
  • Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices
  • Enrolled in another investigational drug, device or biologic study
  • Life expectancy of less than one year
  • Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
  • Rutherford classification of 0, 1, 5 or 6.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Clinic Leipzig

    Leipzig, Saxony, 04103

Other trials in Germany

About this study

Official title: Prospective, Randomized, Multi-Center Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease With the Ranger Paclitaxel Coated PTA Balloon Catheter (Study Arm) Versus the IN.PACT Drug Eluting Balloon (Control Arm)

To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal Artery in Peripheral Artery Disease (PAD) patients with Rutherford class 2-4.

Read the detailed description

This study is a prospective, multi-center 1:1 randomized trial. Patients will be stratified according to lesion length (≤ 10 cm/ > 10 cm and < 20 cm / > 20 cm and ≤ 30 cm). Each strata will include approximately 138 patients.

The trial is to investigate the safety and efficacy of the Ranger™ Drug Coated Balloon in comparison to the IN.PACT™ Drug Coated Balloon in patients with symptomatic femoropopliteal artery disease.

All enrolled subjects will be followed through to 24 months to assess the incidence of restenosis by ultrasound and major adverse events (MAE). Follow-up visits occur at 1, 6, 12 and 24-month intervals per local standard of care. Telephone follow-up visits will occur at 36, 48 and 60 month.

Up to 414 patients will be enrolled at approximately 10-18 sites in Germany for comparison between the following two groups:

Treatment with the Ranger™ Paclitaxel Coated Balloon Catheter (Boston Scientific Corporation, Natick, MA, USA) vs. the IN.PACT™ Drug Eluting Balloon (Medtronic Inc., Minneapolis, MI, USA).

Being tested
Ranger Drug Eluting Balloon, In Pact Drug Eluting Balloon
Medical subject headings
Peripheral Arterial Disease

What participants receive

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

  • Ranger Drug Eluting BalloonDevice

    Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries

  • In Pact Drug Eluting BalloonDevice

    Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries

Study groups in NCT02701543
Study groupRoleWhat they receive
Ranger Drug Eluting BalloonActive comparatorIntervention with Over the Wire (OTW) Percutaneous transluminal angioplasty (PTA )balloon catheter with a semi-compliant balloon coated with a formulation of 2μg/mm2 paclitaxel and acetyl tri-n-butyl citrate (ATBC) as carrier substance
Receives: Device: Ranger Drug Eluting Balloon
In Pact Drug Eluting BalloonActive comparatorIntervention with Over the Wire (OTW) peripheral balloon catheter. The balloon surface is coated with a formulation of 3μg/mm2 paclitaxel and urea as carrier substance.
Receives: Device: In Pact Drug Eluting Balloon

What is being measured

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

  1. Patency rate

    Efficacy: patency rate after one year defined as absence of clinically driven Target Lesion Revascularization (due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure ) or restenosis with Peak Velocity Ratio > 2.4 evaluated by Duplex Ultrasound

    Measured: 1 year

  2. Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization

    Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization

    Measured: 1 year

Secondary outcomes (5)

  1. Target Lesion Revascularization (TLR) rate

    Target Lesion Revascularization rate at 6, 12, 24, 36, 48 and 60 months

    Measured: 6,12,24 months

  2. Walking capacity

    Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6, 12 and 24 months versus baseline.

    Measured: 6,12,24 months

  3. binary restenosis

    Duplex-defined binary restenosis (Peak systolic velocity ratio >2.4) of the target lesion post-procedure and at 6, 12 and 24 months or at any time of re-intervention

    Measured: 6,12,24 months

  4. improvement shift in Rutherford classification

    Sustained clinical improvement: an improvement shift in the Rutherford classification of one class in amputation and Target Vessel Revascularization free surviving patients at 12 months

    Measured: 6,12,24 months

  5. secondary Safety

    Composite of freedom from device and procedure-related death through 60 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization

    Measured: 60 months

Timeline

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

  1. First posted8 Mar 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2018
  4. Study completionDec 2023

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
None (open label)
Enrolment
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02701543
Sponsor's protocol ID
CIP_14/001
Status last verified
Dec 2023
First submitted
19 Jan 2016
Last updated
20 Dec 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Steiner S, Schmidt A, Zeller T, Tepe G, Thieme M, Maiwald L, Schroder H, Euringer W, Popescu C, Brechtel K, Brucks S, Blessing E, Schuster J, Langhoff R, Schellong S, Weiss N, Beschorner U, Wittig T, Scheinert D. Low-Dose vs High-Dose Paclitaxel-Coated Balloons for Femoropopliteal Lesions: 2-Year Results From the COMPARE Trial. JACC Cardiovasc Interv. 2022 Oct 24;15(20):2093-2102. doi: 10.1016/j.jcin.2022.08.004. Epub 2022 Sep 28.

    PubMed 36265942

  • Steiner S, Schmidt A, Zeller T, Tepe G, Thieme M, Maiwald L, Schroder H, Euringer W, Ulrich M, Brechtel K, Brucks S, Blessing E, Schuster J, Langhoff R, Schellong S, Weiss N, Scheinert D. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J. 2020 Jul 14;41(27):2541-2552. doi: 10.1093/eurheartj/ehaa049.

    PubMed 31989155

Questions about this trial

What is this clinical trial studying?

A study testing Ranger Drug Eluting Balloon and In Pact Drug Eluting Balloon in people with Peripheral Artery Disease, run by University of Leipzig at 1 site in Germany.

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 9 inclusion and 14 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 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

Patency rate (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT02701543, which also lists 2 linked publications.

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 20 Dec 2023.

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