AcoArt Ⅰ / SFA China
11. juli 2018 opdateret af: Acotec Scientific Co., Ltd
Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)
The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100853
- Chinese PLA General Hospital
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Beijing, Beijing, Kina, 100091
- Xiyuan Hospital CACMS
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Chongqing
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Chongqing, Chongqing, Kina
- The First Affiliated Hospital of Chongqing Medical University
-
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Fujian
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Fuzhou, Fujian, Kina
- The First Affiliated Hospital of Fujian Medical University
-
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Guangdong
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Guangzhou, Guangdong, Kina
- The First Affiliated Hospital, Sun Yat-sen University
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Hebei
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Shijiazhuang, Hebei, Kina, 050000
- The second Hospital Of Hebei University
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Liaoning
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Dalian, Liaoning, Kina
- The First Affiliated Hospital, Dalian Medical University
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Shenyang, Liaoning, Kina
- The People's Hospital of Liaoning Province
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Shanghai
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Shanghai, Shanghai, Kina, 200032
- Zhongshan Hospital Fudan University
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Shanghai, Shanghai, Kina
- Renji Hospital Shanghai Jiaotong University School of Medicine
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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 40cm
- 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
- 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
- target lesion can't be cross by the guide wire
- 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 2 years)
- patients unable or unwilling to participate this trial
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: drug eluting balloon catheter
use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
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Andre navne:
|
|
Aktiv komparator: common balloon catheter(uncoated drug)
use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Late Lumen Loss
Tidsramme: 6 months
|
measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Minimal lumen diameter (MLD)
Tidsramme: 6 months
|
measure minimal lumen diameter (MLD) of target lesion
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6 months
|
|
Restenosis rate of target vessel
Tidsramme: 6 months, 12 months, 18 months, 24months
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stenosis over 50% is defined as restenosis
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6 months, 12 months, 18 months, 24months
|
|
target lesion revascularization
Tidsramme: 6 months, 12 months, 18 months, 24 months
|
target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
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6 months, 12 months, 18 months, 24 months
|
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change in Rutherford stage
Tidsramme: 6 months, 12 months, 18 months, 24 months
|
based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment Stage clinical symptom 0 asymptomatic
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6 months, 12 months, 18 months, 24 months
|
|
change in ankle brachial index(ABI)
Tidsramme: 6 months
|
change in ankle brachial index(ABI) compared to pretreatment
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6 months
|
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major amputation
Tidsramme: 6 months, 12 months, 18 months, 24 months
|
major amputation at the index limb(major amputation is defined as an amputation above the foot)
|
6 months, 12 months, 18 months, 24 months
|
|
Death
Tidsramme: 12 months, 18 months, 24 months
|
death of any cause
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12 months, 18 months, 24 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Ren H, Liu J, Zhang J, Zhuang B, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W. Five-Year Outcomes of Post-Drug-Coated Balloon Angioplasty Dissection in Complex Femoropopliteal Artery Disease. Int J Gen Med. 2021 Aug 5;14:4197-4207. doi: 10.2147/IJGM.S316916. eCollection 2021.
- Sun G, Liu J, Jia S, Zhang J, Zhuang B, Jia X, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W; AcoArt I Trial Investigators. Comparison of drug-coated balloon angioplasty versus uncoated balloon angioplasty in treatment of total occlusions with severe femoropopliteal lesions: An additional analysis from the AcoArt I study. Vascular. 2021 Jun;29(3):340-349. doi: 10.1177/1708538120953663. Epub 2020 Sep 9.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2013
Primær færdiggørelse (Faktiske)
1. august 2016
Studieafslutning (Faktiske)
1. september 2016
Datoer for studieregistrering
Først indsendt
27. april 2013
Først indsendt, der opfyldte QC-kriterier
7. maj 2013
Først opslået (Skøn)
9. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juli 2018
Sidst verificeret
1. december 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- acotec-02
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .