NCT05391815

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
74mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Apr 2021Jun 2032

Study Start

First participant enrolled

April 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2032

Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

6.2 years

First QC Date

May 23, 2022

Last Update Submit

May 23, 2022

Conditions

Peripheral Arterial Disease

Keywords

Aortoiliac Occlusive Disease

Outcome Measures

Primary Outcomes (1)

  • Freedom from clinically-driven TLR

    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.

    60 months

Secondary Outcomes (6)

  • Technical success rate

    30 days

  • Incidence of major adverse events.

    1month, 3 months,6 months, 12 months ,24 months

  • Adverser events related to insufficient lower limb blood supply.

    1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

  • CD-TLR

    1 month, 3 months, 6 months, 12 months, 24 months, 36 months

  • Vascular quality of life questionnaire(VascuQol)

    1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The TASC C\&D Aorta-iliac occlusion patients.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, China

RECRUITING

Related Publications (9)

  • 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.

    PMID: 23914850BACKGROUND

  • 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.

    PMID: 27099281BACKGROUND

  • 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.

    PMID: 27345516BACKGROUND

  • 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.

    PMID: 17140820RESULT

  • 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.

    PMID: 24796898RESULT

  • 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.

    PMID: 18804943RESULT

  • 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.

    PMID: 27633164RESULT

  • 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.

    PMID: 12764261RESULT

  • 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.

    PMID: 18847642RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Central Study Contacts

Zhenyu Shi, MD,PhD

CONTACT

+86021-64041990shizhenyumax@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

April 1, 2021

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2032

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations

CN(1)