PADNCT02752100
A Study on the Effects of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors(EILRF)
A study testing Percutaneous transluminal angioplasty in people with PAD, run by Third Military Medical University at 1 site in China.
Trial summary
Along with the improvement of living standard, the prevalence of Lower extremity arterial occlusive disease (LEAOD) is also increasing, which has become an important cause of lower extremity amputation and greatly affected the patients' life quality. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- PAD
- What is being tested?
- Percutaneous transluminal angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age between 40-90 years old.
- Ankle-brachial index(ABI)<0.9.
- Lower extremity arterial CT shows that the arterial stenosis>50%
Who cannot join
- Type 2 diabetes with acute complications.
- Type 1 diabetes.
- Cerebrovascular diseases in the last 3 months.
- Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 3 months.
- Hemorrhagic disease.
- Hypohepatia (AST or AST is twice higher than the upper limit) or cirrhosis, hepatic encephalopathy.
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- History of dialysis.
- Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hypoxemia.
- Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
- Fertile woman without contraceptives.
- Allergic to iodine.
- Unable to understanding and follow the study protocol orientations.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The third hospital affiliated to the Third Military Medical University
Chongqing, 400042
Zhiming Zhu, MD, PhD, 86-023-68705094, zhuzm@yahoo.com
Zhiming Zhu, MD, PhD
About this study
Official title: Long-term Prognosis of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors
Along with the improvement of living standard, the prevalence of Lower extremity arterial occlusive disease (LEAOD) is also increasing, which has become an important cause of lower extremity amputation and greatly affected the patients' life quality. Currently, percutaneous transluminal angioplasty (PTA), including balloon dilatation and stent implantation, has been regarded as the most widely applied and accepted treatment for LEAOD. The therapeutic effects of lower extremity interventional treatment, varied in different reports. It was reported that the therapeutic effects were influenced by some traditional risk factors, including age, gender, smoking, and so on. More risk factors are still unknown. The difference of therapeutic effects, the endpoint events were compared between interventional and conventional treatment group to analyze the effect of interventional treatment on LEAOD and explore its risk factors.
- Conditions
- PAD
- Being tested
- Percutaneous transluminal angioplasty
- Keywords
- Lower Extremity Arterial Occlusive Disease, Interventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transluminal angioplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Interventional Therapy | Experimental | Percutaneous transluminal angioplasty. Receives: Procedure: Percutaneous transluminal angioplasty |
| Non-Interventional Therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle-brachial index
Measured: Change from baseline at 1 year(End of Trial)
Mortality(%)
Measured: 1 year(End of Trial)
Incidence of amputation(%)
Measured: 1 year(End of Trial)
Secondary outcomes (10)
Incidence of major adverse cardiac events (MACE)(%)
Measured: 1 year(End of Trial)
High-sensitive C reactive protein(mg/L)
Measured: Change from baseline at 1 year(End of Trial)
Fasting plasma glucose(mmol/L)
Measured: Change from baseline at 1 year(End of Trial)
Blood pressure(mmHg)
Measured: Change from baseline at 1 year(End of Trial)
HbA1c(%)
Measured: Change from baseline at 1 year(End of Trial)
triglyceride(mmol/L)
Measured: Change from baseline at 1 year(End of Trial)
total cholesterol(mmol/L)
Measured: Change from baseline at 1 year(End of Trial)
LDL-c(mmol/L)
Measured: Change from baseline at 1 year(End of Trial)
HDL-c(mmol/L)
Measured: Change from baseline at 1 year(End of Trial)
The lower limb transcutaneous oxygen pressure(mmHg)
Measured: Change from baseline at 1 year(End of Trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PADStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752100
- Sponsor's protocol ID
- EILRF
- Status last verified
- Apr 2016
- First submitted
- 17 Mar 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhang Q, Liu X, Li Q, Liu Y, He H, Wang K, Yan Z. Quantitative model for assessment of lower-extremity perfusion in patients with diabetes. Med Phys. 2023 May;50(5):3019-3026. doi: 10.1002/mp.16214. Epub 2023 Jan 16.
PubMed 36617729
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Prognosis of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors
- ClinicalTrials.gov ID
- NCT02752100
- Acronym / sponsor ID
- EILRF
- Conditions
- PAD
- Keywords
- Lower Extremity Arterial Occlusive Disease, Interventional Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Feb 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 26 Apr 2016 (estimated)
- 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.
Along with the improvement of living standard, the prevalence of Lower extremity arterial occlusive disease (LEAOD) is also increasing, which has become an important cause of lower extremity amputation and greatly affected the patients' life quality. Currently, percutaneous transluminal angioplasty (PTA), including balloon dilatation and stent implantation, has been regarded as the most widely applied and accepted treatment for LEAOD. The therapeutic effects of lower extremity interventional treatment, varied in different reports. It was reported that the therapeutic effects were influenced by some traditional risk factors, including age, gender, smoking, and so on. More risk factors are still unknown. The difference of therapeutic effects, the endpoint events were compared between interventional and conventional treatment group to analyze the effect of interventional treatment on LEAOD and explore its risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Therapy | Experimental | Procedure: Percutaneous transluminal angioplastyPercutaneous transluminal angioplasty. |
| Non-Interventional Therapy | No intervention | – |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, age between 40-90 years old.
- Ankle-brachial index(ABI)<0.9.
- Lower extremity arterial CT shows that the arterial stenosis>50%
Key exclusion criteria (12 listed)
- Type 2 diabetes with acute complications.
- Type 1 diabetes.
- Cerebrovascular diseases in the last 3 months.
- Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 3 months.
- Hemorrhagic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous transluminal angioplasty | Procedure or surgery | Interventional Therapy |
Primary outcome
Ankle-brachial index
Time frame: Change from baseline at 1 year(End of Trial)
Mortality(%)
Time frame: 1 year(End of Trial)
Incidence of amputation(%)
Time frame: 1 year(End of Trial)
10 secondary outcomes
Incidence of major adverse cardiac events (MACE)(%)
Time frame: 1 year(End of Trial)
High-sensitive C reactive protein(mg/L)
Time frame: Change from baseline at 1 year(End of Trial)
Fasting plasma glucose(mmol/L)
Time frame: Change from baseline at 1 year(End of Trial)
Blood pressure(mmHg)
Time frame: Change from baseline at 1 year(End of Trial)
HbA1c(%)
Time frame: Change from baseline at 1 year(End of Trial)
triglyceride(mmol/L)
Time frame: Change from baseline at 1 year(End of Trial)
total cholesterol(mmol/L)
Time frame: Change from baseline at 1 year(End of Trial)
LDL-c(mmol/L)
Time frame: Change from baseline at 1 year(End of Trial)
HDL-c(mmol/L)
Time frame: Change from baseline at 1 year(End of Trial)
The lower limb transcutaneous oxygen pressure(mmHg)
Time frame: Change from baseline at 1 year(End of Trial)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Derived from this study: PubMed 36617729Zhang Q, Liu X, Li Q, Liu Y, He H, Wang K, Yan Z. Quantitative model for assessment of lower-extremity perfusion in patients with diabetes. Med Phys. 2023 May;50(5):3019-3026. doi: 10.1002/mp.16214. Epub 2023 Jan 16.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous transluminal angioplasty in people with PAD, run by Third Military Medical University 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 26 Apr 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhencheng, MD (86-023-68757882, zhenchengyan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle-brachial index (time frame: Change from baseline at 1 year(End of Trial)). The study lists 3 primary outcomes in all. 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 NCT02752100, which also lists 1 linked publication.
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 Apr 2016.