Peripheral Arterial DiseaseALLIANCENCT04966767
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.
Trial summary
This is a prospective, multicenter, real-world, registry study, which aims to observe the intermediate and long-term efficacy of different endovascular treatments for TASC C\&D aortoiliac occlusive disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 31 Dec 2027
- How long will I take part?
- 5 Years
- 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: patients with TASC C\&D aortoiliac occlusive disease
Who may be able to join
- Rutherford classification of 3-6
- Willing to comply with all follow-up evaluations at the specified times
- Target lesion(s) located within the native infrarenal abdominal aorta and/or common iliac artery and/or external iliac artery
- Evidence of ≥ 50% stenosis, restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s), or arterial thrombosis underwent PMT or CDT
- Provides written informed consent
Who cannot join
- Contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, or any other drug used during the study
- Known hypersensitivity to contrast material that cannot be adequately pretreated
- Bleeding diathesis or coagulopathy, known hypercoagulable condition or refuses blood transfusion
- Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures
- Life expectancy less than 24 months
- Current participation in an investigational drug or other device study
- Severe comorbid conditions
- Myocardial infarction or stroke within 3 months prior to enrollment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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 is a prospective, multicenter, real-world, registry study, which aims to observe the intermediate and long-term efficacy of different endovascular treatments for TASC C\&D aortoiliac occlusive disease.
Read the detailed description
Currently, the optimal therapy for TASC C and D type aortic occlusive disease is still controversial. The evidence comes from several singe-center studies with small sample size. In addition, the long-term efficacy of stent implantation and drug coated device in aortic occlusive disease remains unclear, which might be affected by the type of stent and calcification extent. Thus, this study aims to observe the intermediate and long-term efficacy of different endovascular treatments for TASC C\&D aortoiliac occlusive disease in multiple centers.
- Conditions
- Peripheral Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Free from clinically-drived target lesion reintervention
TLR was defined as a reintervention performed for >50% diameter stenosis or in the target lesion after documentation of recurrent clinical symptoms following the index procedure or bailout stenting during the index procedure. Freedom form 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: 5 years
Secondary outcomes (6)
Technique success rate
Successfully revascularize the target vessel. The residual stenosis is <30% and there is no acute thrombosis occurred in the target vessel within 30 days post-operation. The Technical success rate was defined as the rate of the number of patients who receive the treatment as intended verse the number of the patients enrolled.
Measured: 30 days
Perioperative adverse events
Perioperative 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: 30 days
Primary patency rate
The primary patency rate was defined as the percentage of stent patency examined by ultrasonograpy or computed tomography angiography examination of lower limb arteries during follow-up.
Measured: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Incidence of adverse blood supply events
Incidence of adverse blood supply events include anyone of the following: acute or chronic occlusion of target lower extremity, major or minor amputation of a vascular etiology
Measured: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
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: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Total Cost of treatment
All the cost related to the target vessel and spent in the inpatient ward will be recorded and analyzed. Health economics evaluation
Measured: 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, 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, Huashan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966767
- Sponsor's protocol ID
- B2021-426
- Acronym
- ALLIANCE
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. 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
- NCT04966767
- Acronym / sponsor ID
- ALLIANCE / B2021-426
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Not yet 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, Huashan Hospital
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Jul 2021 (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.
This is a prospective, multicenter, real-world, registry study, which aims to observe the intermediate and long-term efficacy of different endovascular treatments for TASC C\&D aortoiliac occlusive disease.
Detailed description
Currently, the optimal therapy for TASC C and D type aortic occlusive disease is still controversial. The evidence comes from several singe-center studies with small sample size. In addition, the long-term efficacy of stent implantation and drug coated device in aortic occlusive disease remains unclear, which might be affected by the type of stent and calcification extent. Thus, this study aims to observe the intermediate and long-term efficacy of different endovascular treatments for TASC C\&D aortoiliac occlusive disease in multiple centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with TASC C\&D aortoiliac occlusive disease
Key inclusion criteria (5 listed)
- Rutherford classification of 3-6
- Willing to comply with all follow-up evaluations at the specified times
- Target lesion(s) located within the native infrarenal abdominal aorta and/or common iliac artery and/or external iliac artery
- Evidence of ≥ 50% stenosis, restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s), or arterial thrombosis underwent PMT or CDT
- Provides written informed consent
Key exclusion criteria (8 listed)
- Contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, or any other drug used during the study
- Known hypersensitivity to contrast material that cannot be adequately pretreated
- Bleeding diathesis or coagulopathy, known hypercoagulable condition or refuses blood transfusion
- Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures
- Life expectancy less than 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
Free from clinically-drived target lesion reintervention
Time frame: 5 years
TLR was defined as a reintervention performed for >50% diameter stenosis or in the target lesion after documentation of recurrent clinical symptoms following the index procedure or bailout stenting during the index procedure. Freedom form 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
Technique success rate
Time frame: 30 days
Perioperative adverse events
Time frame: 30 days
Primary patency rate
Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Incidence of adverse blood supply events
Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Vascular quality of life questionnaire(VascuQol)
Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Total Cost of treatment
Time frame: 3 years, 5 years
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 19 Jul 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Shanghai Zhongshan Hospital.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 (0021 13564690539, maxshizhenyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free from clinically-drived target lesion reintervention (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2021.