Acotec DCB Post Market Clinical Follow-up (FLOWER)

Acotec Scientific

Status

Enrolling

Conditions

Peripheral Artery Disease

Treatments

Device: 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.

Study type

Observational

Funder types

Industry

Identifiers

NCT04393389

Acotec-07

Details and patient eligibility

About

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

Full description

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.

Enrollment

3,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Patient is ≥ 18 years old at the time of consent.
1. 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.
1. 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.
1. 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.
1. Rutherford Classification Category 2-6 Subjects with Rutherford Category 2 have gone through a conservative therapy without success.
1. Inflow lesion treated prior to target lesion treatment

Exclusion criteria

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