Actively Recruiting
Acotec DCB Post Market Clinical Follow-up
Led by Acotec Scientific Co., Ltd · Updated on 2024-08-01
3000
Participants Needed
7
Research Sites
351 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Acotec DCB Post Market Clinical Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years old or older at the time of consent.
- Significant narrowing (70% or more) or blockage of new or restenotic lesions in iliac, superficial femoral, popliteal, or infra-popliteal arteries suitable for angioplasty.
- Lesions can be treated with AcoArt Orchid, Tulip, or Litos drug-coated balloon devices per current instructions for use.
- Subject has provided written informed consent and agrees to comply with protocol examinations and follow-up.
- Rutherford Classification Category 2 to 6, with Category 2 subjects having failed conservative therapy.
- Inflow lesion treated before target lesion treatment.
You will not qualify if you...
- Rutherford Classification Category 0 or 1.
- Currently enrolled in other investigational interventional studies interfering with study endpoints.
- Unable to tolerate required antithrombotic or antiplatelet therapies.
- Non-dilatable severely calcified lesion.
- Known allergy to components of the investigational device.
- Untreated acute or subacute thrombus in the target lesion.
- Life expectancy less than 1 year.
- Pregnancy, lactation, or female patient with childbearing potential not using adequate contraception.
- Other comorbidities limiting longevity or likelihood of protocol compliance as judged by investigator.
- Myocardial infarction or stroke within 30 days prior to the procedure.
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Halle
Halle, Saxony-Anhalt, Germany
Actively Recruiting
2
Eilenburg
Eilenburg, Germany
Actively Recruiting
3
Department of Angiology, University Hospital Leipzig,
Leipzig, Germany
Actively Recruiting
4
Elblandklinikum Radebeul
Radebeul, Germany
Actively Recruiting
5
Elblandklinikum Radebeul
Riesa, Germany
Actively Recruiting
6
REGIOMED Klinikum Sonneberg
Sonneberg, Germany
Actively Recruiting
7
KKH Torgau
Torgau, Germany
Actively Recruiting
Research Team
S
Schmidt Andrej
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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