Acotec DCB Post Market Clinical Follow-up

Официальное название

All Comers Post Market Clinical Follow-up to Continue the Surveillance of the Acotec Drug Coated PTA Catheter Orchid, Tulip and Litos in Lower Limb Treatment

Обзор

All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical Category (RCC) 4-6

Подробное описание

To prospectively collect and assess safety and efficacy data on the AcoArt drug-coated PTA balloon catheters carrying the CE Mark per current Instructions for Use in a real-world cohort of patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.

Вмешательства

• Устройство AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd.
  All comers Post Market Clinical Follow-up to continue the surveillance of the Acotec Drug Coated PTA Catheter AcoArt Orchid, AcoArt Tulip and AcoArt Litos in lower limb treatment

Первичные конечные точки

• Primary efficacy endpoint - non-CLI group [Срок оценки: 12 Months]
• Primary efficacy endpoint -CLI group [Срок оценки: 6 Months]
• Primary safety endpoint- non-CLI group [Срок оценки: 30 days]
• Primary safety endpoint- CLI group [Срок оценки: 12 Months]

Вторичные конечные точки (12)

• Rate of Any TLR (including clinically-driven and incidental TLR) [Срок оценки: 6 months,12 months,24 months, 36months,48 months,60 months]
• Rate of Target vessel revascularization (TVR) [Срок оценки: 6 months,12 months,24 months, 36months,48 months,60 months]
• Rate of Target limb revascularization [Срок оценки: 6 months,12 months,24 months, 36months,48 months,60 months]
• Rate of CD-TLR [Срок оценки: 6 months,12 months,24 months, 36months,48 months,60 months]
• Rate of All-cause mortality [Срок оценки: 6 months,12 months,24 months, 36months,48 months,60months]
• Rate of Device- or procedure-related death [Срок оценки: 30 days, 6 months]
• Rate of Major amputation [Срок оценки: 6 months,12 months,24 months, 36months,48 months,60 months]
• Rate of Technical success [Срок оценки: Post procedure]
• Rate of Procedural success [Срок оценки: Post procedure]
• Change in Rutherford clinical category (target limb) [Срок оценки: 6 months,12 months,24 months, 36months,48 months,60 months]
• Rate of primary sustained clinical improvement [Срок оценки: 6 months,12 months,24 months, 36months,48 months,60 months]
• Rate of secondary sustained clinical improvement [Срок оценки: 6 months,12 months,24 months, 36months,48 months,60 months]

Критерии участия

Критерии включения

• 1\. Patient is ≥ 18 years old at the time of consent.
• 2\. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in iliac, superficial femoral, popliteal and/or infra-popliteal arteries suitable for angioplasty per operator visual assessment.
• 3\. Lesion(s) can be treated with available AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") DCB device per current IFU.
• 4\. Subject has provided written informed consent prior to participation in the PMCF, understands the purpose of this PMCF and agrees to comply with all protocol-specified examinations and follow-up appointments.
• 5\. Rutherford Classification Category 2-6 Subjects with Rutherford Category 2 have gone through a conservative therapy without success.
• 6\. Inflow lesion treated prior to target lesion treatment

Критерии исключения

• 1\. Rutherford Classification Category 0, 1
• 2\. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints
• 3\. Inability to tolerate required antithrombotic or antiplatelet therapies.
• 4\. Non-dilatable severely calcified lesion.
• 5\. Known hypersensitivity/allergy to components of the investigational device
• 6\. Un-treated acute or subacute thrombus in the target lesion.
• 7\. Life expectancy < 1 year.
• 8\. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
• 9\. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
• 10\. Myocardial infarction or stroke within 30 days prior to index procedure.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 7 центров

• Halle — Halle
• Eilenburg — Eilenburg
• Department of Angiology, University Hospital Leipzig, — Leipzig
• Elblandklinikum Radebeul — Radebeul
• Elblandklinikum Radebeul — Riesa
• REGIOMED Klinikum Sonneberg — Sonneberg
• KKH Torgau — Torgau

Идентификаторы

NCT: NCT04393389 · Acotec-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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