Clinical trial NCT03267056: AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China
Official title: Real-World Registry Assessing the Clinical Use of the Orchid Drug Coated Balloon Catheter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Keywords: drug-coated balloon
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
First posted: 2017-08-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

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.

Eligibility 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

Primary outcomes:
measure: Primary patency of target lesion.
timeFrame: 12 months
Secondary outcomes:
measure: target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
timeFrame: 6 months, 12 months
measure: improvment in Rutherford stage
timeFrame: 6 months, 12 months
measure: change in ankle brachial index(ABI)
timeFrame: 12 months
measure: Device success during the operation
timeFrame: during the operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Shijiazhuang
country: China
facility: The second hospital of hebei medical university
state: Hebei
city: Harbin
country: China
facility: The second affiliated hospital of Harbin medical university
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan central hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Tianjin
country: China
facility: Tianjin First Center Hospital
state: Tianjin
city: Nanjing
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Chinese PLA General Hospital
name: Wei Guo
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University First Hospital
name: Yinghua Zou
role: PRINCIPAL_INVESTIGATOR
References: