Overview

This trial is active, not recruiting.

Condition peripheral artery disease
Treatments drug eluting balloon catheter (trade name: orchid), common percutaneous transluminal angioplasty balloon catheter (trade name: admiral)
Sponsor Acotec Scientific Co., Ltd
Start date April 2013
End date August 2016
Trial size 200 participants
Trial identifier NCT01850056, acotec-02

Summary

The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
drug eluting balloon catheter (trade name: orchid) drug eluting dilation catheter
(Active Comparator)
use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery
common percutaneous transluminal angioplasty balloon catheter (trade name: admiral) common PTA catheter

Primary Outcomes

Measure
Late Lumen Loss
time frame: 6 months

Secondary Outcomes

Measure
Minimal lumen diameter (MLD)
time frame: 6 months
Restenosis rate of target vessel
time frame: 6 months, 12 months, 18 months, 24months
target lesion revascularization
time frame: 6 months, 12 months, 18 months, 24 months
change in Rutherford stage
time frame: 6 months, 12 months, 18 months, 24 months
change in ankle brachial index(ABI)
time frame: 6 months
major amputation
time frame: 6 months, 12 months, 18 months, 24 months
Death
time frame: 12 months, 18 months, 24 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - 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 40cm - signed Patient informed consent form Exclusion Criteria: - plasma Cr level greater than 150 umol/L 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 - target lesion can't be cross by the guide wire - 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 2 years) - patients unable or unwilling to participate this trial

Additional Information

Official title Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Acotec Scientific Co., Ltd.