AcoArt Ⅰ / SFA China

Peripheral Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850056
• Other study ID #: acotec-02
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: September 2016

Study information

• Verified date: December 2015
• Source: Acotec Scientific Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• drug eluting balloon catheter (trade name: Orchid)

• common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	Xiyuan Hospital CACMS	Beijing	Beijing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital, Dalian Medical University	Dalian	Liaoning
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Renji Hospital ShangHai Jiaotong University School Of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	The People's Hospital of Liaoning Province	Shenyang	Liaoning
China	The second Hospital Of Hebei University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Acotec Scientific Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late Lumen Loss	measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months	6 months
Secondary	Minimal lumen diameter (MLD)	measure minimal lumen diameter (MLD) of target lesion	6 months
Secondary	Restenosis rate of target vessel	stenosis over 50% is defined as restenosis	6 months, 12 months, 18 months, 24months
Secondary	target lesion revascularization	target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion	6 months, 12 months, 18 months, 24 months
Secondary	change in Rutherford stage	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; mild claudication; moderate claudication; severe claudication; ischemic rest pain; minor tissue loss; ulceration or gangrene	6 months, 12 months, 18 months, 24 months
Secondary	change in ankle brachial index(ABI)	change in ankle brachial index(ABI) compared to pretreatment	6 months
Secondary	major amputation	major amputation at the index limb(major amputation is defined as an amputation above the foot)	6 months, 12 months, 18 months, 24 months
Secondary	Death	death of any cause	12 months, 18 months, 24 months