AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China

Peripheral Artery Disease Clinical Trial

Official title:

Real-World Registry Assessing the Clinical Use of the Orchid Drug Coated Balloon Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267056
• Other study ID #: Acotec-04
• Status: Completed
• Start date: January 19, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2020
• Source: Acotec Scientific Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1, 2020
• Est. primary completion date: April 30, 2020
• 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 20cm

• 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

• 2 or more than 2 stenosis lesions in traget vessel

• 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

• have >30% residual stenosis or blood-limited dissection after predilation

• 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 1 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)
use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The second affiliated hospital of Harbin medical university	Harbin	Heilongjiang
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital of Zhejiang University	Nanjing	Zhejiang
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The second hospital of hebei medical university	Shijiazhuang	Hebei
China	Tianjin First Center Hospital	Tianjin	Tianjin
China	Wuhan central hospital	Wuhan	Hubei

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	Primary patency of target lesion.	The primary efficacy end point was primary patency at 12 months following the index procedure, defined as freedom from clinically driven target lesion revascularization and restenosis as determined by a duplex ultrasonography-derived peak systolic velocity ratio of; =2.4	12 months
Secondary	target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion	target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion	6 months, 12 months
Secondary	improvment in Rutherford stage	improvementin Rutherford stage is defined as an upward shift of at least 1 category on Rutherford classification as compared to baseline	6 months, 12 months
Secondary	change in ankle brachial index(ABI)	change in ankle brachial index(ABI) compared to baseline	12 months
Secondary	Device success during the operation	Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).	during the operation