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Peripheral Arterial DiseaseSIGNATURENCT04971772

SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries

An observational study of Peripheral Arterial Disease and Superficial Femoral Artery Stenosis, run by Cardionovum GmbH at 11 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of this study is to demonstrate the superiority in safety and efficacy of the Legflow DCB vs standard uncoated POBA in a randomized controlled (RCT) for treatment of patients with symptomatic peripheral artery disease (PAD) due to stenosis, restenosis or occlusion of the femoral and/or popliteal arteries. Read more about this study

Who is it for?
Ages 18 years and older
How many people
150 participants
Where
11 sitesin 3 countries
Study dates
8 Jun 2022to Jan 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Patients with peripheral arterial disease in the SFA, eligible for treatment with the paclitaxel coated Legflow dilatation balloon catheter

Who may be able to join

  • Patient is ≥18 years
  • Patient has Rutherford Classification 2,3 or4.
  • Patient has provided written informed consent and is willing to comply with study follow-up requirements.
  • De novo stenotic or occlusive lesion(s) or non-stented restenotic or occlusive lesion(s) occurring >90 days after prior plain old balloon (POBA) angioplasty or >180 days after prior DCB treatment.
  • Target lesion is located between the ostium of the SFA and the end of the P1 segment of the popliteal artery
  • Target vessel diameter ≥ 4 mm and ≤ 7 mm
Show all 12Show fewer
  • Target lesion must be stenotic or occlusive lesion ≤ 150mm in length (one long lesion or tandem lesions) by investigator's visual estimate. [Note: tandem lesions must have a total length of ≤ 150 mm by visual estimate and be separated by ≤ 30 mm.]
  • Target lesion must have angiographic evidence of ≥ 70 % stenosis by investigator's visual estimation
  • Successful, uncomplicated crossing of the target lesion occurs when the tip of the guidewire is distal to the target lesion without the occurrence of flow-limiting dissection of perforation and is judged by visual inspection to be within the true lumen. Subintimal dissection techniques may be used if re-entry occurs above-the-knee (ATK) and without the use of re-entry devices.
  • Target lesion is located at least 30mm from any stent if target vessel was previously stented.
  • A patent inflow artery free from significant stenosis ((≥50% stenosis) as confirmed by angiography.
  • At least one patent native outflow artery to the ankle or foot, free from significant stenosis (≥ 50 % stenosis) as confirmed by angiography.

Who cannot join

  • Acute Limb Ischemia
  • Patient underwent an intervention involving the target vessel within the previous 90 days.
  • Patient underwent any lower extremity percutaneous treatment in the ipsilateral limb using plain old balloon (POBA) angioplasty within the previous 90 days.
  • Patient underwent a percutaneous transluminal angioplasty (PTA) of the target lesion using a DCB within the previous 180 days.
  • Pregnant women or women who are intending to become pregnant.
  • Patient has a life expectancy of less than 1 year
Show all 26Show fewer
  • Patient has a known allergy to contrast medium that cannot be adequately pre-medicated.
  • Patient is allergic to all anti-platelet treatments
  • Patient is receiving immunosuppressant therapy
  • Patient has platelet count <100.000/mm3 or >700.000/mm
  • Patient has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the study procedure
  • Patient is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT)
  • Patient has history of stroke within past 90 days
  • Patient has history of myocardial infarction within the past 30 days.
  • Patient is participating in an investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study.
  • Patient has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure
  • An intervention in the contralateral limb, planned within 30 days post-index procedure
  • Patient had previous bypass surgery of the target lesion
  • Patient had previous treatment of the target vessel with thrombolysis or surgery
  • Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol
  • Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5 mm)
  • Target Lesion requires treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy or re-entry devices
  • Significant target vessel tortuosity or other parameters prohibiting access to the target lesion
  • Presence of thrombus in the target vessel
  • Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤ 30 % residual diameter stenosis without death or major complications.
  • Presence of an aortic, iliac or femoral artificial graft.

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

Germany7 sites

  • Kreiskrankenhaus Alsfeld

    Alsfeld, 36304

  • Sankt Gertrauden-Krankenhaus Berlin

    Berlin, State of Berlin, 10713

  • Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

    Hamburg, 69469

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • SRH Klinikum Karlsbad-Langenseinbach GmbH

    Karlsruhe, 76307

  • St. Franziskus-Hospital GmbH

    Münster, 48145

  • GRN-Klinik Weinheim

    Weinheim, 69120

Other trials in Germany

Brazil2 sites

  • Coris Medicina Vascular

    Florianópolis, 88020-210

  • Hospital Universitario da Universidade Federal de Santa Cataria

    Florianópolis, 88040-900

Other trials in Brazil

Switzerland2 sites

  • Inselspital, Universitätsspital Bern

    Bern, 3010

  • Hôpital de la Providence

    Neuchâtel, 2000

Other trials in Switzerland

About this study

Official title: SIGNATURE Study: Post-market, Randomized Controlled, Multicenter, Single Blinded Prospective Trial Investigating the Paclitaxel-Coated Balloon (Legflow DCB) Treatment Versus Uncoated Balloon Angioplasty Treatment for Femoro-popliteal Lesions.

The aim of this study is to demonstrate the superiority in safety and efficacy of the Legflow DCB vs standard uncoated POBA in a randomized controlled (RCT) for treatment of patients with symptomatic peripheral artery disease (PAD) due to stenosis, restenosis or occlusion of the femoral and/or popliteal arteries.

Medical subject headings
Peripheral Arterial Disease, Peripheral Vascular Diseases

What participants receive

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

Study groups in NCT04971772
Study groupRoleWhat they receive
DCB (Legflow .035") grouptreatment with Drug Coated Balloon angioplasty with the Legflow .035" Paclitaxel Balloon Dilatation catheter.
POBA grouptreatment with standard POBA (uncoated) angioplasty (type and brand at the physician's discretion)

What is being measured

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

  1. Primary Efficacy Endpoint:

    The primary efficacy endpoint is time to clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any reintervention at the target lesion due to symptoms OR drop of ankle brachial index (ABI) > 20 % OR ABI > 0.15 compared to the post-procedural ABI.

    Measured: 12 months post-procedure

  2. Device- and procedure-related death

    Primary Safety Endpoint:

    Freedom from device- and procedure-related death through 30 days post-index procedure;

    Measured: 30 days post-procedure

  3. Major target limb amputation and clinically-driven target vessel revascularization

    Primary Safety Endpoint:

    A composite of (2.1) time to major target limb amputation (above-the-ankle (ATA)) through 12 months post-procedure and (2.2) time to clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure

    Measured: 12 months post-procedure

Secondary outcomes (16)

  1. Acute device success

    defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure

    Measured: during index procedure

  2. Acute procedural success

    Acute procedural success is defined as restoration of the target lesion with ≤30% residual stenosis in the final angiogram.

    Measured: during index procedure

  3. Secondary safety endpoint at discharge up to 30 days post-index procedure

    Secondary safety endpoint is a composite of (3.1) freedom from all cause death (3.2) freedom from major target limb amputation (3.3) freedom from CD-TVR

    Measured: 30 days post-operative

  4. Sustained clinical improvement at 6-, 12- and 24- months post-index procedure

    Clinical improvement is defined as a composite of (4.1) freedom from major target limb amputation, (4.2) freedom from TVR, (4.3) freedom from worsening target limb Rutherford class (compared to baseline) (4.4) freedom from decrease in target limb ankle brachial index (ABI) ≥0.15 (compared to baseline)

    Measured: 6, 12, 24-months post-procedure

  5. Major Adverse Events (MAEs) at 6-, 12- and 24-months post-index procedure

    MAEs are defined as composite of (5.1) all-cause death, (5.2) CD-TVR (5.3) major target limb amputation (5.4) thrombosis at the target lesion

    Measured: 6, 12, 24-months post-procedure

  6. Primary Patency at 6-, 12- and 24-months

    The primary patency is defined as a composite of (6.1) freedom from clinically-driven target lesion revascularization (CD-TLR)

    (6.2) freedom from binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis)

    • For discharge and 12-months: assessed by independent Core Lab

    Measured: 6, 12, 24-months post-procedure

  7. Target Lesion Revascularization at 6-, 12- and 24-months post-index procedure

    defined as a reintervention to maintain or restore the patency in the target lesion. TLR is clinically-driven (CD) when the TLR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure.

    Measured: 6, 12, 24-months post-procedure

  8. Target Vessel Revascularization at 6-, 12- and 24-months post-index procedure

    defined as a reintervention to maintain or restore the patency in the target vessel. TVR is clinically-driven (CD) when the TVR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure

    Measured: 6, 12, 24-months post-procedure

  9. Binary restenosis at 6-, 12- and 24-months

    defined as a restenosis confirmed by DUS PSVR ≥2.4 or ≥50% stenosis (For 12-month: assessed by Independent Core-Lab)

    Measured: 6, 12, 24-months post-procedure

  10. Major Target Limb Amputation at 6-, 12- and 24-months

    defined as an amputation above the ankle (ATA) in the target limb

    Measured: 30- days, 6, 12, 24-months post-procedure

  11. Thrombosis at the target lesion at 6-, 12- and 24-months

    Thrombosis at the target lesion at 6-, 12- and 24-months

    Measured: 6, 12, 24-months post-procedure

  12. All-cause death at 6-, 12- and 24-months

    All-cause death at 6-, 12- and 24-months

    Measured: 30- days, 6, 12, 24-months post-procedure

  13. Change in target limb Rutherford Classification from baseline to 6-, 12- and 24-months

    Change in Target Limb Rutherford Classification from baseline to 6-, 12- and 24-months

    Measured: 6, 12, 24-months post-procedure

  14. Change in Target Limb Resting ABI or TBI from baseline to 6-, 12- and 24-months

    Change in Target Limb Resting ABI or TBI from baseline to 6-, 12- and 24-months

    Measured: 6, 12, 24-months post-procedure

  15. Improvement of life quality according to the Walking Impairment Questionnaire (WIQ) and the EQ-5D Questionnaire to baseline at follow-up at 6-, 12- and 24-month.

    Improvement of life quality according to the Walking Impairment Questionnaire (WIQ) and the EQ-5D Questionnaire to baseline at follow-up at 6-, 12- and 24-month.

    Measured: 6, 12, 24-months post-procedure

  16. device- and procedure-related death

    Freedom from device- and procedure-related death at discharge, 30 days, 6-, 12- and 24-months

    Measured: 30- days, 6, 12, 24-months post-procedure

Timeline

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

  1. First posted21 Jul 2021
  2. Study start8 Jun 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04971772
Sponsor's protocol ID
FCRE-210621
Acronym
SIGNATURE
Status last verified
Mar 2026
First submitted
20 Jul 2021
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease and Superficial Femoral Artery Stenosis, run by Cardionovum GmbH 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 26 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. 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, Brazil, Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

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?

Primary Efficacy Endpoint: (time frame: 12 months post-procedure). The study lists 3 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 NCT04971772.

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 19 Mar 2026.

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