Status:
COMPLETED
AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China
Lead Sponsor:
Acotec Scientific Co., Ltd
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18-80 years
Brief Summary
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 Femora...
Detailed 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 pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03267056
Start Date
January 19 2018
End Date
June 1 2020
Last Update
August 19 2020
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
2
Peking University First Hospital
Beijing, Beijing Municipality, China
3
The second hospital of hebei medical university
Shijiazhuang, Hebei, China
4
The second affiliated hospital of Harbin medical university
Harbin, Heilongjiang, China