SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
Launched by CARDIONOVUM GMBH · Jul 20, 2021
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
The SIGNATURE Study is investigating a new treatment option for patients with Peripheral Arterial Disease (PAD), particularly those with narrowed or blocked arteries in the legs. The trial is comparing a special type of balloon called the Legflow Drug-Coated Balloon (DCB) to the standard treatment, which is a plain old balloon angioplasty (POBA). The goal is to see if the Legflow DCB is safer and more effective for improving blood flow in the femoral and popliteal arteries.
To participate in this study, you must be at least 18 years old and have certain symptoms of PAD. You also need to have specific types of artery blockages that haven't been treated in the past 90 to 180 days. Potential participants should have a target blockage that is between 4 mm and 7 mm wide and at least 70% narrowed. If you join the study, you will receive either the Legflow DCB or the standard treatment, and you will be monitored closely to see how well the treatment works. This trial is currently recruiting participants and is open to all genders. If you're considering this treatment, it's important to discuss your medical history and any concerns with your healthcare provider to see if you qualify.
Gender
ALL
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.
About Cardionovum Gmbh
Cardionovum GmbH is a leading clinical trial sponsor specializing in innovative cardiovascular therapies and medical devices. Committed to advancing patient care, the company focuses on developing cutting-edge solutions that address unmet medical needs in the cardiovascular field. With a robust portfolio of clinical studies, Cardionovum GmbH collaborates with healthcare professionals and research institutions to ensure the efficacy and safety of its products. Their dedication to rigorous scientific research and adherence to regulatory standards positions them at the forefront of cardiovascular innovation, ultimately aiming to improve patient outcomes and enhance quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Heidelberg, , Germany
Münster, , Germany
Berlin, , Germany
Hamburg, , Germany
Karlsbad, , Germany
Weinheim, , Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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