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.
Study Type
OBSERVATIONAL
Enrollment
150
Coris Medicina Vascular
Florianópolis, Brazil
Hospital Universitario da Universidade Federal de Santa Cataria
Florianópolis, Brazil
Sankt Gertrauden-Krankenhaus Berlin
Berlin, State of Berlin, Germany
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.
Time frame: 12 months post-procedure
Device- and procedure-related death
Primary Safety Endpoint: Freedom from device- and procedure-related death through 30 days post-index procedure;
Time frame: 30 days post-procedure
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
Time frame: 12 months post-procedure
Acute device success
defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure
Time frame: during index procedure
Acute procedural success
Acute procedural success is defined as restoration of the target lesion with ≤30% residual stenosis in the final angiogram.
Time frame: during index procedure
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
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Kreiskrankenhaus Alsfeld
Alsfeld, Germany
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
Hamburg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
SRH Klinikum Karlsbad-Langenseinbach GmbH
Karlsruhe, Germany
St. Franziskus-Hospital GmbH
Münster, Germany
GRN-Klinik Weinheim
Weinheim, Germany
Inselspital, Universitätsspital Bern
Bern, Switzerland
...and 1 more locations
Time frame: 30 days post-operative
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)
Time frame: 6, 12, 24-months post-procedure
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
Time frame: 6, 12, 24-months post-procedure
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
Time frame: 6, 12, 24-months post-procedure
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.
Time frame: 6, 12, 24-months post-procedure
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
Time frame: 6, 12, 24-months post-procedure
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)
Time frame: 6, 12, 24-months post-procedure
Major Target Limb Amputation at 6-, 12- and 24-months
defined as an amputation above the ankle (ATA) in the target limb
Time frame: 30- days, 6, 12, 24-months post-procedure
Thrombosis at the target lesion at 6-, 12- and 24-months
Thrombosis at the target lesion at 6-, 12- and 24-months
Time frame: 6, 12, 24-months post-procedure
All-cause death at 6-, 12- and 24-months
All-cause death at 6-, 12- and 24-months
Time frame: 30- days, 6, 12, 24-months post-procedure
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
Time frame: 6, 12, 24-months post-procedure
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
Time frame: 6, 12, 24-months post-procedure
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.
Time frame: 6, 12, 24-months post-procedure
device- and procedure-related death
Freedom from device- and procedure-related death at discharge, 30 days, 6-, 12- and 24-months
Time frame: 30- days, 6, 12, 24-months post-procedure