Acotec DCB Post Market Clinical Follow-up

Recruiting now

Conditions studied: Peripheral Artery Disease

In brief

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

Key facts

Study ID: NCT04393389
Run by: Acotec Scientific Co., Ltd
People needed: 3000
Starts: 2020-06-04
Expected to finish: 2027-03-01
Last updated by the study team: 2024-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Halle — Halle, Saxony-Anhalt, Germany (enrolling)
Eilenburg — Eilenburg, Germany (enrolling)
Department of Angiology, University Hospital Leipzig, — Leipzig, Germany (enrolling)
Elblandklinikum Radebeul — Radebeul, Germany (enrolling)
Elblandklinikum Radebeul — Riesa, Germany (enrolling)
REGIOMED Klinikum Sonneberg — Sonneberg, Germany (enrolling)
KKH Torgau — Torgau, Germany (enrolling)

Full record on ClinicalTrials.gov

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