AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China

Acotec Scientific

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Device: drug eluting balloon catheter (trade name: Orchid)

Study type: Observational

Funder types: Industry

Identifiers

NCT03267056

Acotec-04

Details and patient eligibility

About

The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).

Full description

PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia.

DEBs are designed to promote arterial patency by reducing neointimal proliferation.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 80 years
• Patients with peripheral artery disease (PAD), with Rutherford classification between 2 and 5
• an occlusion or a minimum grade of stenosisPrimary over 70% in the superficial femoral artery an /or the popliteal artery
• Total length of treat lesion(s)is less or equal to 20cm
• signed Patient informed consent form

Exclusion criteria

• plasma Cr level greater than 150 umol/L in patients
• patients with acute thrombosis requiring lysis or thrombectomy
• 2 or more than 2 stenosis lesions in traget vessel
• patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks
• patient requiring intervention in both lower limbs at the same time
• have >30% residual stenosis or blood-limited dissection after predilation
• distal outflow through less than one lower leg vessel
• known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
• patients participating in another clinical trials with interfere with this trial in the past 3 months
• pregnancy and lactating woman
• untreatable bleeding diatheses
• other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patients's life expectancy(less than 1 years)
• patients unable or unwilling to participate this trial

Trial design

120 participants in 1 patient group

DCB arm

Description:

drug eluting balloon catheter

Treatment:

Device: drug eluting balloon catheter (trade name: Orchid)