Actively Recruiting
All Comers Post Market Clinical Follow-up to Continue Surveillance of Acotec Drug Coated PTA Catheters Orchid, Tulip, and Litos in Lower Limb Treatment
Led by Acotec Scientific Co., Ltd · Updated on 2024-08-01
3000
Participants Needed
7
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the AcoArt drug-coated percutaneous transluminal angioplasty (PTA) balloon catheters in patients with symptomatic peripheral artery disease undergoing lower limb revascularization. This observational study includes patients with varying severity of arterial disease, classified by Rutherford Clinical Categories 2-6, to monitor real-world outcomes following standard treatment practices. Participants will receive treatment using one of three types of AcoArt drug-coated PTA balloon catheters—Orchid, Tulip, or Litos—designed for arteries in the lower limbs. The study is a single-arm, multi-center follow-up that observes outcomes without altering usual care, focusing on two patient groups: those with moderate symptoms (Rutherford 2-3) and those with critical limb ischemia (Rutherford 4-6). Throughout the study, participants will undergo various assessments to track safety and treatment effectiveness at multiple time points, including 30 days, 6 months, 12 months, and up to 60 months. Researchers will collect data on clinical improvements, wound healing, need for additional procedures, survival rates, and amputation rates. Patients are expected to attend follow-up visits and comply with study protocols for monitoring and data collection during this extended observation period.
CONDITIONS
Brief Title
Acotec DCB Post Market Clinical Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years or older at the time of consent
- Significant narrowing (70% or more) or blockages in de-novo or restenotic lesions in iliac, superficial femoral, popliteal, or infra-popliteal arteries suitable for angioplasty
- Lesions can be treated with AcoArt Orchid (0.035"), Tulip (0.018"), or Litos (0.014") drug-coated balloon catheters per current instructions for use
- Provided written informed consent and agrees to follow study protocol and appointments
- Rutherford Clinical Category between 2 and 6; Category 2 patients have tried conservative therapy without success
- Inflow lesion treated before target lesion treatment
You will not qualify if you...
- Rutherford Clinical Category 0 or 1
- Currently enrolled in other investigational interventional studies that interfere 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 or female patients of childbearing potential not using adequate contraceptives or currently breastfeeding
- Other medical conditions limiting longevity or compliance with follow-up
- Myocardial infarction or stroke within 30 days prior to the procedure
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants undergo treatment with the AcoArt drug-coated PTA balloon catheters as part of routine lower limb revascularization care.
1 procedure visit (in-person)
Duration - Up to 60 months
Participants are followed to collect safety and efficacy data after the device procedure, including assessments up to 60 months.
Follow-up visits at 30 days, 6 months, 12 months, and annually up to 60 months
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
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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