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

• Sponsor: Acotec Scientific Co., Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03267056
• Collaborator: (none)
• Enrollment: 120
• Locations: 10
• Actual Duration (Months): 28.4
• Patients Per Site: 12
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease	Device: drug eluting balloon catheter (trade name: Orchid)

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Real-World Registry Assessing the Clinical Use of the Orchid Drug Coated Balloon Catheter
• Actual Study Start Date: Jan 19, 2018
• Actual Primary Completion Date: Apr 30, 2020
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
DCB arm drug eluting balloon catheter	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

Outcome Measures

Primary Outcome Measures

1. Primary patency of target lesion. [12 months]

   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

Secondary Outcome Measures

1. target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion [6 months, 12 months]

   target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion

2. improvment in Rutherford stage [6 months, 12 months]

   improvementin Rutherford stage is defined as an upward shift of at least 1 category on Rutherford classification as compared to baseline

3. change in ankle brachial index(ABI) [12 months]

   change in ankle brachial index(ABI) compared to baseline

4. Device success during the operation [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese PLA General Hospital	Beijing	Beijing	China	100853
2	Peking University First Hospital	Beijing	Beijing	China
3	The second hospital of hebei medical university	Shijiazhuang	Hebei	China
4	The second affiliated hospital of Harbin medical university	Harbin	Heilongjiang	China
5	Wuhan central hospital	Wuhan	Hubei	China
6	Jiangsu Province Hospital	Nanjing	Jiangsu	China
7	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning	China
8	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China
9	Tianjin First Center Hospital	Tianjin	Tianjin	China
10	The First Affiliated Hospital of Zhejiang University	Nanjing	Zhejiang	China

Sponsors and Collaborators

• Acotec Scientific Co., Ltd

Investigators

• Principal Investigator: Wei Guo, Chinese PLA General Hospital
• Principal Investigator: Yinghua Zou, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Acotec Scientific Co., Ltd
• ClinicalTrials.gov Identifier: NCT03267056
• Other Study ID Numbers: Acotec-04
• First Posted: Aug 30, 2017
• Last Update Posted: Aug 19, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Acotec Scientific Co., Ltd: drug-coated balloon
• Additional relevant MeSH terms: Peripheral Arterial Disease

Study Results

No Results Posted as of Aug 19, 2020