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.

Peripheral Arterial Disease Clinical Trial

Official title:

Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease: a Prospective, Multicenter, Real-world, Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391815
• Other study ID #: The ALLIANCE Study
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: June 1, 2032

Study information

• Verified date: May 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Zhenyu Shi, MD,PhD
• Phone: +86021-64041990
• Email: shizhenyumax[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 1, 2032
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Rutherford grades 3-6.

2. Follow the follow-up arrangement.

3. Age: 18-80 years old.

4. The target lesions were in the lower abdominal aorta and/or the common iliac artery and/or the external iliac artery.

5. 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.

6. Signed informed consent.

Exclusion Criteria:

1. Known allergy to drugs used in this study, including antiplatelet or anticoagulant drugs, etc.

2. Allergy to iodine contrast agent allergy;

3. Coagulation dysfunction or hypercoagulability;

4. Breast-feeding or pregnant women;

5. Life expectancy < 24 months;

6. Body condition can not tolerate endovascular treatment;

7. Type 2B, type 3 lower limb ischemia patients

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai

Sponsors (10)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Chengdu University of Traditional Chinese Medicine, First Affiliated Hospital of Zhejiang University, First People's Hospital of Hangzhou, Huashan Hospital, Liyuan Hospital of Tongji Medical College of Huazhong University of Science and Technology, Qingdao Hiser Medical Group, RenJi Hospital, Second Affiliated Hospital of Soochow University, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (9)

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- — View Citation

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. Review. — View Citation

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.2008.0 — View Citation

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. Review. — View Citation

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. — View Citation

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, Crea — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from clinically-driven TLR	CD-TLR was de?ned 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	Technical success rate	We defined the technical success rate as the rate of patients in whom the endovascular treatments are successfully performed.	30 days
Secondary	Incidence of major adverse events.	Major adverse events include anyone of the following: all-cause mortality, Myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology, and arterial thrombosis related to endovascular manipulation.	1month, 3 months,6 months, 12 months ,24 months
Secondary	Adverser events related to insufficient lower limb blood supply.	Major amputation, acute re-occlusion, subacute re-occlusion and chronic re-occlusion.	1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	CD-TLR	CD-TLR was de?ned as any reintervention within the target lesion(s) because of recurrent symptoms.	1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Secondary	Vascular quality of life questionnaire(VascuQol)	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.	1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Secondary	Health economics evaluation	All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed.	60 months