AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China
- Conditions
- Peripheral Artery Disease
- Interventions
- Procedure: common PTA balloon catheterProcedure: DEB catheter
- Registration Number
- NCT02137577
- Lead Sponsor
- Acotec Scientific Co., Ltd
- Brief Summary
The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.
- 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 85 years
- Patients with peripheral artery disease (PAD), with Rutherford classification between 4 and 6
- an occlusion or a minimum grade of stenosis Primary over 70% in the below popliteal artery
- The expected survival time is more than 1 year
- signed Patient informed consent form
- Serum creatinine clearance rate less than 30ml/min in patients
- patients with acute thrombosis requiring lysis or thrombectomy
- 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
- In-stent restenosis in the blow-knee popliteal artery
- target lesion can't be cross by the guide wire
- the stenosis rate of proximal outflow more than 30% with or without intervention
- the length of the stenosis or occlusion in proximal outflow(including the Iliac artery, the superficial femoral artery, the Popliteal artery) more than 150mm before intervention
- stenosis or occlusion of distal outflow for below-the-ankle artery.
- expected major amputations at the index limb before intervention
- known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
- patients participating in another clinical trials with interfere with this trial in the same time
- pregnancy and lactating woman
- untreatable bleeding diatheses
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description common PTA balloon catheter common PTA balloon catheter use common PTA balloon catheter(trade name:Amphirion Deep) to treat stenosis or occlusion in below popliteal artery of control group DEB catheter DEB catheter use DEB catheter(trade name: Lotus/Tulip) to treat the stenosis or occlusion in below popliteal artery of experimental arm
- Primary Outcome Measures
Name Time Method Primary Patency [Time Frame: 6 months] 6 months Freedom from target vessel occlusion and clinically driven target lesion reintervention
- Secondary Outcome Measures
Name Time Method Ulcer healing rate 6 months, 12 months Healed or not, if not, improving,stagnant, worsening
device success rate during the operation(after using the DEB catheter) DEB catheter can reach the target lesions, expand as expected(not broken), and withdraw successfully.
technical success rates during the operation(after using the DEB catheter) The blood supply of the target lesion recovered after treatment, and residual stenosis less than 50%
if occured clinically driven TLR( target lesion revascularization) 6 months, 12 months,18 months, 24 months Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as: resting pain occur again, ulcer deterioration, new foot ulcers
target lesion late lumen loss 6 months 6 months measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
Ulcer healing time 6 months, 12 months, 18 months, 24 months Healed or not
operation success rate during the operation(after using the DEB catheter) both device succeed and technical succeed, and without clinical complication
limb salvage in surviving subjects 30 days, 6 months, 12 months,18 months, 24 months No Amputation of target limb
Change from baseline ankle brachial index(ABI) at 6 months 6 months measure ankle brachial index
\>1.3 Vascular wall calcification is severe
0.9\~1.1 Normal range
0.5\~0.8 Mild and moderate ischemia of lower limb arteries
\<0.5 severe ischemiachange from baseline Rutherford stage at 6 months 6 months, 12 months,18 months, 24 months based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment
Stage clinical symptom
0 asymptomatic
1. mild claudication
2. moderate claudication
3. severe claudication
4. ischemic rest pain
5. minor tissue loss
6. ulceration or gangrene
Trial Locations
- Locations (11)
People's Liberation Army General Hospital
🇨🇳BeiJing, China
The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Xiyuan Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China