Clinical trial NCT04971772: SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Superficial Femoral Artery Stenosis
Angiopathy, Peripheral
Lead sponsor: Cardionovum GmbH
Sponsor class: INDUSTRY
Collaborators: name: FCRE (Foundation for Cardiovascular Research and Education)
First posted: 2021-07-21
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with peripheral arterial disease in the SFA, eligible for treatment with the paclitaxel coated Legflow dilatation balloon catheter

Brief 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.


Eligibility criteria: Inclusion criteria

* 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
* 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.

Exclusion criteria:

* 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
* 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.

Primary outcomes:
measure: Primary Efficacy Endpoint:
timeFrame: 12 months post-procedure
measure: Device- and procedure-related death
timeFrame: 30 days post-procedure
measure: Major target limb amputation and clinically-driven target vessel revascularization
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Acute device success
timeFrame: during index procedure
measure: Acute procedural success
timeFrame: during index procedure
measure: Secondary safety endpoint at discharge up to 30 days post-index procedure
timeFrame: 30 days post-operative
measure: Sustained clinical improvement at 6-, 12- and 24- months post-index procedure
timeFrame: 6, 12, 24-months post-procedure
measure: Major Adverse Events (MAEs) at 6-, 12- and 24-months post-index procedure
timeFrame: 6, 12, 24-months post-procedure
measure: Primary Patency at 6-, 12- and 24-months
timeFrame: 6, 12, 24-months post-procedure
measure: Target Lesion Revascularization at 6-, 12- and 24-months post-index procedure
timeFrame: 6, 12, 24-months post-procedure
measure: Target Vessel Revascularization at 6-, 12- and 24-months post-index procedure
timeFrame: 6, 12, 24-months post-procedure
measure: Binary restenosis at 6-, 12- and 24-months
timeFrame: 6, 12, 24-months post-procedure
measure: Major Target Limb Amputation at 6-, 12- and 24-months
timeFrame: 30- days, 6, 12, 24-months post-procedure
measure: Thrombosis at the target lesion at 6-, 12- and 24-months
timeFrame: 6, 12, 24-months post-procedure
measure: All-cause death at 6-, 12- and 24-months
timeFrame: 30- days, 6, 12, 24-months post-procedure
measure: Change in target limb Rutherford Classification from baseline to 6-, 12- and 24-months
timeFrame: 6, 12, 24-months post-procedure
measure: Change in Target Limb Resting ABI or TBI from baseline to 6-, 12- and 24-months
timeFrame: 6, 12, 24-months post-procedure
measure: 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.
timeFrame: 6, 12, 24-months post-procedure
measure: device- and procedure-related death
timeFrame: 30- days, 6, 12, 24-months post-procedure
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Sankt Gertrauden-Krankenhaus Berlin
city: Hamburg
country: Germany
facility: Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Karlsbad
country: Germany
facility: SRH Klinikum Karlsbad-Langenseinbach GmbH
city: Münster
country: Germany
facility: St. Franziskus-Hospital GmbH
city: Weinheim
country: Germany
facility: GRN-Klinik Weinheim
Study officials:
References: