Arterial Occlusive DiseasesNCT03248323
A Prospective Study: the Value of Using iFlow and PBV in the Endovascular Treatment of Infrapopliteal Arterial Occlusive Diseases
An observational study of Arterial Occlusive Diseases, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Color coded blood flow and blood perfusion techniques are applied to the endovascular treatment of infrapopliteal arterial occlusion,to establish a method of quantitative evaluation of blood flow and tissue perfusion,to improve the level of calculation of condition and curative effect. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- dyna-pbv
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jun 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: These new technologies are performed in the treatment of patients older than 40 years. They present with rest pain, intermittent claudication, ulceration or gangrenous. Some of them have the risk factors of CLI, as hypertension, diabetes, hyperlipidemia or smoking. They are referred to our vascular service for CLI-infrapopliteal artery occlusion. Computed tomographic angiography discloses the occlusive lesion in anteriortibial, posterior tibial or peroneal arteries.
Who may be able to join
- Patients are diagnosed as lower limb atherosclerosis occlusion from June 2016 to June 2018 in our centre;
- All participating patients provided written informed consent and willing to participate;
- aged 40 years and more;
- the class of lower ischemia is upon 4;
- below-the-knee arteries stenosis or occlusion is indicated by duplex or computed tomographic angiography;
- there is no heavy stenosis in superficial femoral artery (stenosis<30%), or short length lesion(length≤5cm, stenosis≥30%);
- infection or ulceration don't happen in the area of surgery;
- below the inguinal ligament arteries don't have the history of bypass or interventional surgery.
Who cannot join
- disagree and refuse to the free therapy;
- lesion length of superior artery is more than 5cm;
- history of heart dysfunction: congestive heart failure,, myocardial infarction, severe arrhythmia;
- With severe metabolic disease, renal impairment(serum creatinine>1.4mg/dL, glomerular filtration rate<60) affect the excretion of contrast agents;
- have the diseases or agents which will reduce the viable of data;
- allergy to iodinated contrast medium.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Yupei Zhao, Ph.D
About this study
Official title: A Prospective Study: the Value of Using Parametric Color Coding of Digital Subtraction Angiography and Flat-panel Detector Computed Tomography Parenchymal Blood Volume Imaging in the Endovascular Treatment of Infrapopliteal Arterial Occlusive Diseases
Color coded blood flow and blood perfusion techniques are applied to the endovascular treatment of infrapopliteal arterial occlusion,to establish a method of quantitative evaluation of blood flow and tissue perfusion,to improve the level of calculation of condition and curative effect. So as to establish a new complete evaluation system of infrapopliteal arterial occlusive disease, to guide clinical further. At the same time establish a digital information platform for clinical, lay the foundation for the large research.
- Conditions
- Arterial Occlusive Diseases
- Being tested
- dyna-pbv
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dyna-pbvRadiation
| Study group | Role | What they receive |
|---|---|---|
| pre-con | Not described Receives: Radiation: dyna-pbv |
What is being measured
The primary outcome is the main question the study is designed to answer.
patency rate
We compare the change of blood flow velocity and blood perfusion volume before and after the recanalization of infrapopliteal arteries to assess the initial patency rate. While we test the ankle brachial index and toe brachial index at 3 , 6, 12 months, lower extremity arterial ultrasound at 6 mouths and computed tomographic angiography in 1 year to evaluate the patency of one year.
Measured: 1 year
Secondary outcomes (1)
wound healing rate
This is to evaluate the prognosis of patients who with the foot ulcer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2019 (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 Arterial Occlusive DiseasesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248323
- Sponsor's protocol ID
- A03968
- Status last verified
- Jun 2016
- First submitted
- 9 May 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
Publications
Shao J, Ma J, Lai Z, Yu X, Li K, Xu L, Chen J, Wang C, Cao W, Liu X, Yuan J, Liu B. Impaired pedal arch affects the treatment effect in patients with single tibial artery revascularization demonstrated by intraoperative perfusion. Quant Imaging Med Surg. 2022 Jun;12(6):3204-3212. doi: 10.21037/qims-21-801.
PubMed 35655837
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study: the Value of Using Parametric Color Coding of Digital Subtraction Angiography and Flat-panel Detector Computed Tomography Parenchymal Blood Volume Imaging in the Endovascular Treatment of Infrapopliteal Arterial Occlusive Diseases
- ClinicalTrials.gov ID
- NCT03248323
- Acronym / sponsor ID
- A03968
- Conditions
- Arterial Occlusive Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 14 Aug 2017 (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.
Color coded blood flow and blood perfusion techniques are applied to the endovascular treatment of infrapopliteal arterial occlusion,to establish a method of quantitative evaluation of blood flow and tissue perfusion,to improve the level of calculation of condition and curative effect. So as to establish a new complete evaluation system of infrapopliteal arterial occlusive disease, to guide clinical further. At the same time establish a digital information platform for clinical, lay the foundation for the large research.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pre-con | – | Radiation: dyna-pbv |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- These new technologies are performed in the treatment of patients older than 40 years. They present with rest pain, intermittent claudication, ulceration or gangrenous. Some of them have the risk factors of CLI, as hypertension, diabetes, hyperlipidemia or smoking. They are referred to our vascular service for CLI-infrapopliteal artery occlusion. Computed tomographic angiography discloses the occlusive lesion in anteriortibial, posterior tibial or peroneal arteries.
Key inclusion criteria (8 listed)
- Patients are diagnosed as lower limb atherosclerosis occlusion from June 2016 to June 2018 in our centre;
- All participating patients provided written informed consent and willing to participate;
- aged 40 years and more;
- the class of lower ischemia is upon 4;
- below-the-knee arteries stenosis or occlusion is indicated by duplex or computed tomographic angiography;
Key exclusion criteria (6 listed)
- disagree and refuse to the free therapy;
- lesion length of superior artery is more than 5cm;
- history of heart dysfunction: congestive heart failure,, myocardial infarction, severe arrhythmia;
- With severe metabolic disease, renal impairment(serum creatinine>1.4mg/dL, glomerular filtration rate<60) affect the excretion of contrast agents;
- have the diseases or agents which will reduce the viable of data;
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 |
|---|---|---|
| dyna-pbv | Radiation | pre-con |
Primary outcome
patency rate
Time frame: 1 year
We compare the change of blood flow velocity and blood perfusion volume before and after the recanalization of infrapopliteal arteries to assess the initial patency rate. While we test the ankle brachial index and toe brachial index at 3 , 6, 12 months, lower extremity arterial ultrasound at 6 mouths and computed tomographic angiography in 1 year to evaluate the patency of one year.
1 secondary outcome
wound healing rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Derived from this study: PubMed 35655837Shao J, Ma J, Lai Z, Yu X, Li K, Xu L, Chen J, Wang C, Cao W, Liu X, Yuan J, Liu B. Impaired pedal arch affects the treatment effect in patients with single tibial artery revascularization demonstrated by intraoperative perfusion. Quant Imaging Med Surg. 2022 Jun;12(6):3204-3212. doi: 10.21037/qims-21-801.
Related trials for Arterial Occlusive Diseases
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Enrolling by invitationEarly Phase 1
Clinical Safety and Efficacy Evaluation of the Blood-cooling and Stasis-removing Formula as an Adjunct to Atorvastatin in the Treatment of Hemorrhagic Moyamoya Disease.
Moyamoya Disease
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?
An observational study of Arterial Occlusive Diseases, run by Peking Union Medical College 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 8 inclusion and 6 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 14 Aug 2017. 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 Bao Liu, Ph.D (+86-010-69152502, liubao72@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patency rate (time frame: 1 year). 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 NCT03248323, 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 14 Aug 2017.