AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China

Acotec Scientific

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Procedure: DEB catheter; Procedure: common PTA balloon catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02137577

acotec-03

Details and patient eligibility

About

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.

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 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

DEB catheter

Experimental group

Description:

use DEB catheter(trade name: Lotus/Tulip) to treat the stenosis or occlusion in below popliteal artery of experimental arm

Treatment:

Procedure: DEB catheter

common PTA balloon catheter

Active Comparator group

Description:

use common PTA balloon catheter(trade name:Amphirion Deep) to treat stenosis or occlusion in below popliteal artery of control group

Treatment:

Procedure: common PTA balloon catheter