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

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ClinicalTrials.gov Identifier: NCT03267056
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Acotec Scientific Co., Ltd

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
Peripheral Artery Disease Device: drug eluting balloon catheter (trade name: Orchid)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Real-World Registry Assessing the Clinical Use of the Orchid Drug Coated Balloon Catheter
Actual Study Start Date : January 19, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 1, 2020

Group/Cohort Intervention/treatment
DCB arm 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




Primary Outcome Measures :
  1. Primary patency of target lesion. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 12 months ]
    change in ankle brachial index(ABI) compared to baseline

  4. Device success during the operation [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267056


Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Wei Guo, MD    13910758706    pla301dml@vip.sina.com   
Peking University First Hospital Recruiting
Beijing, Beijing, China
Contact: Xinhua Zou    13801105222    13801105222@139.com   
China, Hebei
The second hospital of hebei medical university Recruiting
Shijiazhuang, Hebei, China
Contact: Wei Bi    15803210532    biwei8115@sohu.com   
China, Heilongjiang
The second affiliated hospital of Harbin medical university Not yet recruiting
Harbin, Heilongjiang, China
Contact: Weiliang Jiang         
China, Hubei
Wuhan central hospital Recruiting
Wuhan, Hubei, China
Contact: Tao He    13507186847    13507186847@163.com   
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China
Contact: Xiwei Zhang    13913016333    xiwei1092@163.com   
China, Tianjin
Tianjin First Center Hospital Recruiting
Tianjin, Tianjin, China
Contact: Ju He    13702158258    hejutian@163.com   
China, Zhejiang
The First Affiliated Hospital of Zhejiang University Recruiting
Nanjing, Zhejiang, China
Contact: Hongkun Zhang    13588819761    doczhk@163.com   
China
Beijing Hospital Not yet recruiting
Beijing, China
Contact: Yongjun Li         
Sponsors and Collaborators
Acotec Scientific Co., Ltd

Additional Information:

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Responsible Party: Acotec Scientific Co., Ltd
ClinicalTrials.gov Identifier: NCT03267056     History of Changes
Other Study ID Numbers: Acotec-04
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: August 2018

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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:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases