This Study is a Prospective, Multi-center, Real World, Observational Study, Which Aims at Evaluating Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease.
23. maj 2022 opdateret af: Shanghai Zhongshan Hospital
Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease: a Prospective, Multicenter, Real-world, Registry Study
This study is a prospective, multi-center, real world, observational study, which aims at evaluating the intermediate and long-term efficacy of endovascular treatment for TASC C&D aortoiliac occlusive disease .It is estimated that 800 subjects diagnosed with TASC C&D aortoiliac occlusive disease and receive endovascular treatments will be enrolled in nine centers from April 2021 to June 2027 nation-widely.
All the subjects will be under follow-up for 60 months.
There is no restriction on the endovascular techniques.
The primary outcomes covers freedom from TLR at 60 months.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
In the past decade, endovascular treatment has become the first-line treatment for iliac artery occlusion, while Aorta - bilateral femoral artery bypass surgery is preferred for more complex iliac artery occlusion. However, recently, with advances in endovascular devices and techniques, endovascular interventions have gradually replaced open surgery in many clinical problems and have shown ideal safety and efficacy.
Currently, the optimal treatment for TASC, C&D iliac artery occlusion is controversial, mostly based on limited data from single centers and few large multicenter databases or registries. In addition, the long-term efficacy of stents implantation in iliac artery disease remind unknown and might be influenced by stent type and calcification. Therefore, the purpose of this study was to evaluate the long-term efficacy and safety of endovascular treatment for TASC, C&D iliac artery occlusion in a multicenter study.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
800
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Zhenyu Shi, MD,PhD
- Telefonnummer: +86021-64041990
- E-mail: shizhenyumax@163.com
Studiesteder
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Shanghai, Kina
- Rekruttering
- Zhongshan Hospital, Fudan University
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Kontakt:
- Zhenyu Shi, MD, PhD
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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
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The TASC C&D Aorta-iliac occlusion patients.
Beskrivelse
Inclusion Criteria:
- Rutherford grades 3-6.
- Follow the follow-up arrangement.
- Age: 18-80 years old.
- The target lesions were in the lower abdominal aorta and/or the common iliac artery and/or the external iliac artery.
- The stenosis degree ≥50%, or restenosis (received PTA or other adjuvant therapy, including bare or covers stents), or complete occlusion, or the presence of aortailiac artery thrombosis after PMT or CDT thrombus clearance, and then further endovascular therapy perfomred.
- Signed informed consent.
Exclusion Criteria:
- Known allergy to drugs used in this study, including antiplatelet or anticoagulant drugs, etc.
- Allergy to iodine contrast agent allergy;
- Coagulation dysfunction or hypercoagulability;
- Breast-feeding or pregnant women;
- Life expectancy < 24 months;
- Body condition can not tolerate endovascular treatment;
- Type 2B, type 3 lower limb ischemia patients
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Freedom from clinically-driven TLR
Tidsramme: 60 months
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CD-TLR was defined as any reintervention within the target lesion(s) because of recurrent symptoms.
Freedom form CD-TLR were defined as the rates of the number of patients who did not receive reintervention verse the number of patients during the follow-up period.
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60 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Forekomst af større uønskede hændelser.
Tidsramme: 1 måned, 3 måneder, 6 måneder, 12 måneder, 24 måneder
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Større uønskede hændelser omfatter enhver af følgende: mortalitet af alle årsager, myokardieinfarkt, iskæmisk slagtilfælde, akut lemmeriskæmi og større amputation af en vaskulær ætiologi og arteriel trombose relateret til endovaskulær manipulation.
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1 måned, 3 måneder, 6 måneder, 12 måneder, 24 måneder
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Technical success rate
Tidsramme: 30 days
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We defined the technical success rate as the rate of patients in whom the endovascular treatments are successfully performed.
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30 days
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Adverser events related to insufficient lower limb blood supply.
Tidsramme: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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Major amputation, acute re-occlusion, subacute re-occlusion and chronic re-occlusion.
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1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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CD-TLR
Tidsramme: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
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CD-TLR was defined as any reintervention within the target lesion(s) because of recurrent symptoms.
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1 month, 3 months, 6 months, 12 months, 24 months, 36 months
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Vascular quality of life questionnaire(VascuQol)
Tidsramme: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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The VascuQol was designed as a questionnaire containing five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items) to evaluate Health related quality of life (HRQL).
Every item has seven response options, with scores ranging from 1 to 7. A total score is the sum of all 25 item scores divided by 25.And both the total score as well as the domain scores range from 1 (worst HRQL) to 7 (best HRQL).The lower the value, the poorer the quality of life.
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1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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Health economics evaluation
Tidsramme: 60 months
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All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed.
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60 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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
- Stoner MC, Calligaro KD, Chaer RA, Dietzek AM, Farber A, Guzman RJ, Hamdan AD, Landry GJ, Yamaguchi DJ; Society for Vascular Surgery. Reporting standards of the Society for Vascular Surgery for endovascular treatment of chronic lower extremity peripheral artery disease. J Vasc Surg. 2016 Jul;64(1):e1-e21. doi: 10.1016/j.jvs.2016.03.420.
- Indes JE, Pfaff MJ, Farrokhyar F, Brown H, Hashim P, Cheung K, Sosa JA. Clinical outcomes of 5358 patients undergoing direct open bypass or endovascular treatment for aortoiliac occlusive disease: a systematic review and meta-analysis. J Endovasc Ther. 2013 Aug;20(4):443-55. doi: 10.1583/13-4242.1.
- Hajibandeh S, Hajibandeh S, Antoniou SA, Torella F, Antoniou GA. Covered vs Uncovered Stents for Aortoiliac and Femoropopliteal Arterial Disease: A Systematic Review and Meta-analysis. J Endovasc Ther. 2016 Jun;23(3):442-52. doi: 10.1177/1526602816643834. Epub 2016 Apr 20.
- Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
- Tshomba Y, Melissano G, Apruzzi L, Baccellieri D, Negri G, Chiesa R. Open repair for aortic occlusive disease: indication, techniques, results, tips and tricks. J Cardiovasc Surg (Torino). 2014 Apr;55(2 Suppl 1):57-68.
- Kashyap VS, Pavkov ML, Bena JF, Sarac TP, O'Hara PJ, Lyden SP, Clair DG. The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction. J Vasc Surg. 2008 Dec;48(6):1451-7, 1457.e1-3. doi: 10.1016/j.jvs.2008.07.004. Epub 2008 Sep 19.
- Dorigo W, Piffaretti G, Benedetto F, Tarallo A, Castelli P, Spinelli F, Fargion A, Pratesi C. A comparison between aortobifemoral bypass and aortoiliac kissing stents in patients with complex aortoiliac obstructive disease. J Vasc Surg. 2017 Jan;65(1):99-107. doi: 10.1016/j.jvs.2016.06.107. Epub 2016 Sep 12.
- Rzucidlo EM, Powell RJ, Zwolak RM, Fillinger MF, Walsh DB, Schermerhorn ML, Cronenwett JL. Early results of stent-grafting to treat diffuse aortoiliac occlusive disease. J Vasc Surg. 2003 Jun;37(6):1175-80. doi: 10.1016/s0741-5214(03)00326-4.
- Hans SS, DeSantis D, Siddiqui R, Khoury M. Results of endovascular therapy and aortobifemoral grafting for Transatlantic Inter-Society type C and D aortoiliac occlusive disease. Surgery. 2008 Oct;144(4):583-9; discussion 589-90. doi: 10.1016/j.surg.2008.06.021.
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 2021
Primær færdiggørelse (Forventet)
1. juni 2027
Studieafslutning (Forventet)
1. juni 2032
Datoer for studieregistrering
Først indsendt
23. maj 2022
Først indsendt, der opfyldte QC-kriterier
23. maj 2022
Først opslået (Faktiske)
26. maj 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. maj 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. maj 2022
Sidst verificeret
1. maj 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- The ALLIANCE Study
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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