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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2020-12-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DEB catheter

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

Group Type EXPERIMENTAL

DEB catheter

Intervention Type PROCEDURE

DEB catheter (trade name: Litos/Tulip)

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

Group Type ACTIVE_COMPARATOR

common PTA balloon catheter

Intervention Type PROCEDURE

common PTA balloon catheter

Interventions

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DEB catheter

DEB catheter (trade name: Litos/Tulip)

Intervention Type PROCEDURE

common PTA balloon catheter

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No