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Status:

RECRUITING

Acotec DCB Post Market Clinical Follow-up

Lead Sponsor:

Acotec Scientific Co., Ltd

Conditions:

Peripheral Artery Disease

Eligibility:

All Genders

18+ years

Brief Summary

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 Isch...

Detailed 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 wi...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 4 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 1 2027

Estimated Enrollment :

3000 Patients enrolled

Trial Details

Trial ID

NCT04393389

Start Date

June 4 2020

End Date

March 1 2027

Last Update

August 1 2024

Active Locations (7)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (7 locations)

1

Halle

Halle, Saxony-Anhalt, Germany

2

Eilenburg

Eilenburg, Germany

3

Department of Angiology, University Hospital Leipzig,

Leipzig, Germany

4

Elblandklinikum Radebeul

Radebeul, Germany