AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China
- Conditions
- Peripheral Artery Disease
- Registration Number
- NCT03267056
- Lead Sponsor
- Acotec Scientific Co., Ltd
- 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 Femoral Artery (SFA) and Popliteal Arteries (PA).
- 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 proliferation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary patency of target lesion. 12 months The primary efficacy end point was primary patency at 12 months following the index procedure, defined as freedom from clinically driven target lesion revascularization and restenosis as determined by a duplex ultrasonography-derived peak systolic velocity ratio of
≤2.4
- Secondary Outcome Measures
Name Time Method Device success during the operation during the operation Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).
improvment in Rutherford stage 6 months, 12 months improvementin Rutherford stage is defined as an upward shift of at least 1 category on Rutherford classification as compared to baseline
change in ankle brachial index(ABI) 12 months change in ankle brachial index(ABI) compared to baseline
target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion 6 months, 12 months target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
Trial Locations
- Locations (10)
The second hospital of hebei medical university
🇨🇳Shijiazhuang, Hebei, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Zhejiang University
🇨🇳Nanjing, Zhejiang, China
Tianjin First Center Hospital
🇨🇳Tianjin, Tianjin, China
The second affiliated hospital of Harbin medical university
🇨🇳Harbin, Heilongjiang, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Wuhan central hospital
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China