Acotec DCB Post Market Clinical Follow-up

Acotec Scientific Co., Ltd3,000 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Peripheral Artery Disease

Interventions

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.DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Locations (7)

Halle

Halle, Saxony-Anhalt, Germany

RECRUITING

Eilenburg

Eilenburg, Germany

RECRUITING

Department of Angiology, University Hospital Leipzig,

Leipzig, Germany

Outcomes

Primary Outcomes

Primary efficacy endpoint - non-CLI group

Freedom from clinically-driven target lesion revascularization (CD-TLR) within 12 months after index procedure, which is defined as any re-intervention within the target lesion(s) due to recurrent clinical symptoms of PAD (increase of one Rutherford class or more) and/or drop of ankle-brachial index (≥20% or \>0.15 when compared with maximum early post-procedural level).

Time frame: 12 Months

Primary efficacy endpoint -CLI group

Freedom from clinically-driven TLR within 6 months after index procedure, which is defined as any re-intervention within the target lesion(s) due to delayed or worsening wound healing, new or recurrent wound, or worsening Rutherford class.

Time frame: 6 Months

Primary safety endpoint- non-CLI group

A composite of freedom from major adverse limb events and perioperative death (MALE-POD) through 30 days after index procedure. A major adverse limb event is defined as above-ankle amputation or major reintervention (ie, new bypass graft, major surgical graft revision such as a jump graft or an interposition graft, or thrombectomy/thrombolysis) of the treated limb.

Time frame: 30 days

Primary safety endpoint- CLI group

A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and TLR within 12 months post-index procedure

Time frame: 12 Months

Secondary Outcomes

Rate of Any TLR (including clinically-driven and incidental TLR)

Any TLR (including clinically-driven and incidental TLR) at 6,12, 24, 36, 48, 60 months post-procedure

Time frame: 6 months,12 months,24 months, 36months,48 months,60 months

Rate of Target vessel revascularization (TVR)

Central Contacts

Schmidt Andrej

CONTACT

+49-341-97 Andrej.Schmidt@medizin.uni-leipzig.de

Data from ClinicalTrials.gov

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