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

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

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).

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital
    • Beijing, Beijing, China
      • Peking University First Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • The Second Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The Second Affiliated Hospital of Harbin Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Central Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital
  • Liaoning
    • Dalian, Liaoning, China
      • The First Affiliated Hospital of Dalian Medical University
    • Shenyang, Liaoning, China
      • Shengjing Hospital of China Medical University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin First Center Hospital
  • Zhejiang
    • Nanjing, Zhejiang, China
      • The First Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with a more than 70% stenosis at femoral and/or popliteal artery meet all the inclusion and excluison criteria

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
change in ankle brachial index(ABI)	change in ankle brachial index(ABI) compared to baseline	12 months
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

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd
• Investigators: Principal Investigator: Wei Guo, Chinese PLA General Hospital; Principal Investigator: Yinghua Zou, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2018
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: drug-coated balloon
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: Acotec-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No