Peripheral Arterial DiseaseNCT05391815

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.

An observational study of Peripheral Arterial Disease, run by Shanghai Zhongshan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Peripheral Arterial Disease
How many people: 800 participants
Where: 1 siteChina
Study dates: 1 Apr 2021to 1 Jun 2032
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhenyu Shi, MD,PhD contact

+86021-64041990

shizhenyumax@163.com

China1 site, 1 recruiting

Zhongshan Hospital, Fudan University
Shanghai
Zhenyu Shi, MD, PhD
Recruiting

Other trials in China

About this study

Official title: 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.

Read the detailed 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.

Conditions: Peripheral Arterial Disease
Keywords: Aortoiliac Occlusive Disease
Medical subject headings: Peripheral Arterial Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 60 months

Secondary outcomes (6)

Technical success rate
We defined the technical success rate as the rate of patients in whom the endovascular treatments are successfully performed.
Measured: 30 days
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.
Measured: 1month, 3 months,6 months, 12 months ,24 months
Adverser events related to insufficient lower limb blood supply.
Major amputation, acute re-occlusion, subacute re-occlusion and chronic re-occlusion.
Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
CD-TLR
CD-TLR was deﬁned as any reintervention within the target lesion(s) because of recurrent symptoms.
Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
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.
Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Health economics evaluation
All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed.
Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20211 Jun 2032

First posted26 May 2022
Study start1 Apr 2021
Primary completion1 Jun 2027 (estimated)
Study completion1 Jun 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 800 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05391815
Sponsor's protocol ID: The ALLIANCE Study
Status last verified: May 2022
First submitted: 23 May 2022
Last updated: 26 May 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 23914850
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.
PubMed 27099281
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.
PubMed 27345516
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.
PubMed 17140820
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.
PubMed 24796898
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.
PubMed 18804943
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.
PubMed 27633164
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.
PubMed 12764261
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.
PubMed 18847642

Interested in taking part?

Zhenyu Shi, MD,PhD

+86021-64041990

shizhenyumax@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
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All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease: a Prospective, Multicenter, Real-world, Registry Study
ClinicalTrials.gov ID: NCT05391815
Acronym / sponsor ID: The ALLIANCE Study
Conditions: Peripheral Arterial Disease
Keywords: Aortoiliac Occlusive Disease
Study type: Observational
Recruitment status: Recruiting
Enrolment: 800 participants (estimated)
Lead sponsor: Shanghai Zhongshan HospitalUniversity, hospital or other
Collaborators: RenJi Hospital, First Affiliated Hospital of Zhejiang University, Chengdu University of Traditional Chinese Medicine, Xuanwu Hospital, Beijing, First People's Hospital of Hangzhou, Qingdao Hiser Medical Group, Second Affiliated Hospital of Soochow University, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Huashan Hospital
Study start: 1 Apr 2021 (actual)
Primary completion: 1 Jun 2027 (estimated)
Study completion: 1 Jun 2032 (estimated)
First posted: 26 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The TASC C\&D Aorta-iliac occlusion patients.

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Freedom from clinically-driven TLR
Time frame: 60 months
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.

6 secondary outcomes

Technical success rate
Time frame: 30 days
Incidence of major adverse events.
Time frame: 1month, 3 months,6 months, 12 months ,24 months
Adverser events related to insufficient lower limb blood supply.
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
CD-TLR
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Vascular quality of life questionnaire(VascuQol)
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Health economics evaluation
Time frame: 60 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
Background: PubMed 23914850Indes 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.
Background: PubMed 27099281Hajibandeh 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.
Background: PubMed 27345516Stoner 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.
Results publication: PubMed 17140820Norgren 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.
Results publication: PubMed 24796898Tshomba 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.
Results publication: PubMed 18804943Kashyap 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.
Results publication: PubMed 27633164Dorigo 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.
Results publication: PubMed 12764261Rzucidlo 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.
Results publication: PubMed 18847642Hans 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.
Individual participant dataSharing planned: Undecided

Related trials for Peripheral Arterial Disease

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Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
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Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Zhenyu Shi, MD,PhD contact

+86021-64041990

shizhenyumax@163.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhenyu Shi, MD,PhD (+86021-64041990, shizhenyumax@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from clinically-driven TLR (time frame: 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05391815, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.