SIGNATURE Study : DCB vs POBA

Overview

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.

Full Title of Study: “SIGNATURE Study: Post-market, Randomized Controlled, Multicenter, Prospective Trial Investigating Efficacy and Safety of Paclitaxel-Coated Drug Coated Balloon (Legflow DCB) Treatment Versus Uncoated Balloon Angioplasty Treatment for Femoro-popliteal Lesions.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 1, 2023

Arms, Groups and Cohorts

  • DCB (Legflow .035″) group
    • treatment with Drug Coated Balloon angioplasty with the Legflow .035″ Paclitaxel Balloon Dilatation catheter.
  • POBA group
    • treatment with standard POBA (uncoated) angiplasty (type and brand at the physician’s discretion)

Clinical Trial Outcome Measures

Primary Measures

  • Primary Efficacy Endpoint:
    • Time Frame: 12 months post-procedure
    • freedom from 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.
  • Primary Safety Endpoint:
    • Time Frame: 12 months post-procedure
    • Composite of: (1) Freedom from device- and procedure-related death through 30-days post-index procedure; (2) Freedom from major target limb amputation (above-the-ankle (ATA)) through 12 months post-procedure and (3) clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure

Secondary Measures

  • Acute device success
    • Time Frame: during index procedure
    • defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure
  • Acute procedural success
    • Time Frame: during index procedure
    • Acute procedural success is defined as restoration of the target lesion with ≤30% residual stenosis in the final angiogram.
  • Secondary safety endpoint at discharge up to 30 days post-index procedure
    • Time Frame: 30 days post-operative
    • defined as freedom from all-cause death, major target limb amputation and CD-TVR through 30 days post index procedure
  • Sustained clinical improvement at 6-, 12- and 24- months post-index procedure
    • Time Frame: 24-months post-operative
    • defined as freedom from major target limb amputation, TVR, worsening target limb Rutherford Class (compared to baseline) and decrease in target limb ankle brachial index (ABI) or toe brachial index (TBI) ≥ 0.15 (compared to baseline)
  • Major Adverse Events (MAEs) at 6-, 12- and 24-months post-index procedure
    • Time Frame: 24-months post-operative
    • defined as composite of all-cause death, CD-TVR and major target limb amputation, or thrombosis at the target lesion
  • Primary Patency at 6-, 12- and 24-months
    • Time Frame: 24-months post-operative
    • defined as a composite of freedom from clinically-driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis) through 24-months post-index procedure. (For 12-months: assessed by independent Core Lab)
  • Target Lesion Revascularization at 6-, 12- and 24-months post-index procedure
    • Time Frame: 24-months post-operative
    • 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.
  • Target Vessel Revascularization at 6-, 12- and 24-months post-index procedure
    • Time Frame: 24-months post-operative
    • 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
  • Binary restenosis at 6-, 12- and 24-months
    • Time Frame: 24-months post-operative
    • defined as a restenosis confirmed by DUS PSVR ≥2.4 or ≥50% stenosis (For 12-month: assessed by Independent Core-Lab)
  • Major Target Limb Amputation at 6-, 12- and 24-months
    • Time Frame: 24-months post-operative
    • defined as an amputation above the ankle (ATA) in the target limb
  • Thrombosis at the target lesion at 6-, 12- and 24-months
    • Time Frame: 24-months post-operative
    • Thrombosis at the target lesion at 6-, 12- and 24-months
  • All-cause death at 6-, 12- and 24-months
    • Time Frame: 24-months post-operative
    • All-cause death at 6-, 12- and 24-months
  • Change in target limb Rutherford Classification from baseline to 6-, 12- and 24-months
    • Time Frame: 24-months post-operative
    • Change in Target Limb Rutherford Classification from baseline to 6-, 12- and 24-months
  • Change in Target Limb Resting ABI or TBI from baseline to 6-, 12- and 24-months
    • Time Frame: 24-months post-operative
    • Change in Target Limb Resting ABI or TBI from baseline to 6-, 12- and 24-months
  • 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.
    • Time Frame: 24-months post-operative
    • 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.

Participating in This Clinical Trial

General inclusion criteria GI1. Patient is ≥18 years GI2. Patient has Rutherford Classification 2,3 or4. GI3. Patient has provided written informed consent and is willing to comply with study follow-up requirements. Angiographic inclusion criteria AI1. 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. AI2. Target lesion is located between the ostium of the SFA and the end of the P1 segment of the popliteal artery AI3. Target vessel diameter ≥ 4 mm and ≤ 7 mm AI4. 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. AI5. Target lesion must have angiographic evidence of ≥ 70 % stenosis by investigator's visual estimation AI6. 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. AI7. Target lesion is located at least 30mm from any stent if target vessel was previously stented. AI8. A patent inflow artery free from significant stenosis ((≥50% stenosis) as confirmed by angiography. AI9. At least one patent native outflow artery to the ankle or foot, free from significant stenosis (≥ 50 % stenosis) as confirmed by angiography. General exclusion criteria:

GE1. Acute Limb Ischemia GE2. Patient underwent an intervention involving the target vessel within the previous 90 days. GE3. Patient underwent any lower extremity percutaneous treatment in the ipsilateral limb using a paclitaxel-eluting stent or DCB within the previous 90 days. GE4. Patient underwent a percutaneous transluminal angioplasty (PTA) of the target lesion using a DCB within the previous 180 days. GE5. Pregnant women or women who are intending to become pregnant. GE6. Patient has a life expectancy of less than 1 year GE7. Patient has a known allergy to contrast medium that cannot be adequately pre-medicated. GE8. Patient is allergic to all anti-platelet treatments GE9. Patient is receiving immunosuppressant therapy GE10. Patient has platelet count <100.000/mm3 or >700.000/mm GE11. Patient has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the study procedure GE12. Patient is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT) GE13. Patient has history of stroke within past 90 days GE14. Patient has history of myocardial infarction within the past 30 days. GE15. 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. GE16. 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 GE17. An intervention in the contralateral limb, planned within 30 days post-index procedure GE18. Patient had previous bypass surgery of the target lesion GE19. Patient had previous treatment of the target vessel with thrombolysis or surgery GE20. 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 Angiographic Exclusion Criteria:

AE1. Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5 mm) AE2. Target Lesion requires treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy or re-entry devices AE3. Significant target vessel tortuosity or other parameters prohibiting access to the target lesion AE4. Presence of thrombus in the target vessel AE5. 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. AE6. Presence of an aortic, iliac or femoral artificial graft.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Prof. Giovanni Torsello
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Prof. Giovanni Torsello, CEO FCRE – FCRE (Foundation for Cardiovascular Research and Education)
  • Overall Contact(s)
    • Annelena Held-Wehmöller, Dr., +4915785128140, annelena.held@fcre.eu

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