Peripheral Artery DiseaseNCT03734549
Predicting Procedural and Long-term Outcomes of Endovascular Revascularization for Lower Extremity Peripheral Artery Chronic Total Occlusions With Computed Tomographic Angiography
An observational study of Peripheral Artery Disease, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Nearly one-half of all lower extremity percutaneous interventions performed in patients with symptomatic peripheral artery disease (PAD) involve chronic total occlusions (CTOs) which are technically more challenging and are associated with more periprocedural complications and lower rates of procedural success… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PAD patients with CTOs confirmed by angiograpy underwent pre-procedue CTA and endovascular revascularization
Who may be able to join
- PAD patients with CTOs confirmed by angiograpy underwent pre-procedue CTA and endovascular revascularization
Who cannot join
- Patients' clinical date were incomplete; The interval between preprocedural CTA and PTA. was more than one month The CTA images could not be evaluated because of motion and metal artifact Loss to follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Ningning Ding, visiting
About this study
Nearly one-half of all lower extremity percutaneous interventions performed in patients with symptomatic peripheral artery disease (PAD) involve chronic total occlusions (CTOs) which are technically more challenging and are associated with more periprocedural complications and lower rates of procedural success comparing with non CTOs. Despite innovate dedicated CTO devices developed and provides higher technical success, a wire-catheter approach to cross peripheral artery CTO is most often the first choice of operators as its lower cost advantage.Subhash Banerjee MD reported of all 1,362 CTOs, wire-catheter approaches were used in 82% and the technical success rate was 65%. If the operators chose wire-catheter as primary crossing device at the beginning of the procedure, but the technically failed with the provisional use of re-entry or crossing devices to try to procedural success. Such procedures add incrementally to procedure duration and cost and the revascularization and amputation rate at 12 month were highly increased comparing with using dedicated CTO devices initially. So it is very important to predict the outcome of guidewire crossing through CTOs to direct the choice of crossing strategy.
Current data suggested that computed tomography angiography (CTA) imaging of PAD and a detailed comprehensive assessment for CTO arteries before endovascular therapy can assist preprocedural planning to maximize procedural success. Previous studies about coronary CTOs prediction scores as the KCCT score and CT-based CT-RECTOR provide the factors including occlusion length, the shape of proximal entry site, severe calcification, and etc. characters base on CTA correlating with the outcome of cross. As the same physiopathologic mechanism, we hypothesized that the radiographic characteristics are connected with outcomes of guidewire crossing occlusions. To our knowledge, few studies focused on how to predict the successful GC through peripheral artery CTO, therefore, the purpose of this study was to establish a simple and clinically applicable prediction model based on CTA characters within the occlusive lesions and clinical parameters to predict the GC outcomes of patients with lower extremity CTO.
In addition, the long-term effect of endovascular revascularization are very important. An analysis concluded that limb adverse event (repeat revascularization rate 17.2%, amputation rates 8.5%) at 12-month in the CTOs with direct wire-catheter crossing strategy. Base on the proven influence factors (the lesion length, small diameter of the vessel and severe calcification, mechanical exposure, etc.)of adverse event at after endovascular revascularization ,we also can establish model with preoperative computer tomography angiography that provided the lesion detail characteristic combing the patients' biochemical and clinical feature to predict the adverse event rate at 12-month after endovascular revascularization.
Read the detailed description
Patients Patients with peripheral artery disease met the inclusion criteria if they were PAD patients, had performed preprocedural CTA and PTA. The hospital's database was used to identify the patients met inclusion criteria. The medical records and radiologic information system database were reviewed to retrieve clinical information including background diseases and radiographic findings.
Computed Tomography Angiography Protocol A 128-section multidetector CT (Philips brillianceiCT was used for scanning with the following scanning parameters，tube voltage was 120 kVp, tube current 40-440mA, and 0.625-mm slice thicknesses. The protocols required patients to lie supine with legs extended, A fixed bolus of contrast medium with total volume of 90 ml (370 mg iodine per milliliter) was injected into antecubital vein at a rate of 4 mL/sec, followed by a 30 mL saline flush, by using a dual-barrel power injector. CT scanning was performed with the coverage from the common iliac artery bifurcation to the tiptoe. Scanning began 12 seconds after an attenuation threshold of 150 HU was reached.
CTA Data Analysis CTA data were transferred to an offline workstation for further analysis. Axial images, cross-sectional views, curved planar reformations (CPR), and multiplanar reformations (MPR), as well as three-dimensional maximum intensity projection images were available for evaluation. We measure the degree of transluminal calcification, CT attenuation value of the proximal occlusion ,anatomic distribution of the leision,and length of occlusion,and the degree of stenosis CTO Crossing Strategy CTO crossing strategy was wire-catheter. Technical success was defined as crossing the CTO and placement of a guidewire in the distal true lumen confirmed by angiography.Outcomes include binary variables of lesion crossing described as technical success or failure.
Follow-up We also examined patient adverse events after procedures at 12 months: all-cause death,nonfatal myocardial infarction,revascularization and amputation.
Built prediction model we can establish model with preoperative computer tomography angiography that provided the lesion detail characteristic combing the patients' biochemical and clinical feature to predict the procedural and long-term outcomes of endovascular revascularization for Lower extremity peripheral artery chronic total occlusions.
- Conditions
- Peripheral Artery Disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| technical success group | Technical success was defined as crossing the CTO and placement of a guidewire in the distal true lumen confirmed by angiography. | |
| technical failure group | Technical failure was defined that guidewire could not crossing through the CTO nor reture to the true lumen by angiography. | |
| had adverse events group | Patients had one of the adverse events such as all-cause death, nonfatal myocardial infarction, repeat revascularization or amputation.at 12 months after procedures. | |
| had no adverse events group | Patients had none adverse events such as all-cause death, nonfatal myocardial infarction, repeat revascularization and amputation at 12 months after procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
technical success
Successful crossing the CTO and placement of a guidewire in the distal true lumen confirmed by angiography
Measured: At time of procedure (day 0)
Secondary outcomes (1)
Composite of Major Adverse Events
the incidence of major adverse events (composite of all-cause death, nonfatal myocardial infarction, repeat revascularization or amputation) during the 12-month study period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Dec 2017
- Primary completionJan 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Yang, archiater, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734549
- Sponsor's protocol ID
- XJTUAF2017LSK-137
- Status last verified
- Jun 2018
- First submitted
- 26 Jun 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Procedural and Long-term Outcomes of Endovascular Revascularization for Lower Extremity Peripheral Artery Chronic Total Occlusions With Computed Tomographic Angiography
- ClinicalTrials.gov ID
- NCT03734549
- Acronym / sponsor ID
- XJTUAF2017LSK-137
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Nov 2018 (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.
Nearly one-half of all lower extremity percutaneous interventions performed in patients with symptomatic peripheral artery disease (PAD) involve chronic total occlusions (CTOs) which are technically more challenging and are associated with more periprocedural complications and lower rates of procedural success comparing with non CTOs. Despite innovate dedicated CTO devices developed and provides higher technical success, a wire-catheter approach to cross peripheral artery CTO is most often the first choice of operators as its lower cost advantage.Subhash Banerjee MD reported of all 1,362 CTOs, wire-catheter approaches were used in 82% and the technical success rate was 65%. If the operators chose wire-catheter as primary crossing device at the beginning of the procedure, but the technically failed with the provisional use of re-entry or crossing devices to try to procedural success. Such procedures add incrementally to procedure duration and cost and the revascularization and amputation rate at 12 month were highly increased comparing with using dedicated CTO devices initially. So it is very important to predict the outcome of guidewire crossing through CTOs to direct the choice of crossing strategy.
Current data suggested that computed tomography angiography (CTA) imaging of PAD and a detailed comprehensive assessment for CTO arteries before endovascular therapy can assist preprocedural planning to maximize procedural success. Previous studies about coronary CTOs prediction scores as the KCCT score and CT-based CT-RECTOR provide the factors including occlusion length, the shape of proximal entry site, severe calcification, and etc. characters base on CTA correlating with the outcome of cross. As the same physiopathologic mechanism, we hypothesized that the radiographic characteristics are connected with outcomes of guidewire crossing occlusions. To our knowledge, few studies focused on how to predict the successful GC through peripheral artery CTO, therefore, the purpose of this study was to establish a simple and clinically applicable prediction model based on CTA characters within the occlusive lesions and clinical parameters to predict the GC outcomes of patients with lower extremity CTO.
In addition, the long-term effect of endovascular revascularization are very important. An analysis concluded that limb adverse event (repeat revascularization rate 17.2%, amputation rates 8.5%) at 12-month in the CTOs with direct wire-catheter crossing strategy. Base on the proven influence factors (the lesion length, small diameter of the vessel and severe calcification, mechanical exposure, etc.)of adverse event at after endovascular revascularization ,we also can establish model with preoperative computer tomography angiography that provided the lesion detail characteristic combing the patients' biochemical and clinical feature to predict the adverse event rate at 12-month after endovascular revascularization.
Detailed description
Patients Patients with peripheral artery disease met the inclusion criteria if they were PAD patients, had performed preprocedural CTA and PTA. The hospital's database was used to identify the patients met inclusion criteria. The medical records and radiologic information system database were reviewed to retrieve clinical information including background diseases and radiographic findings.
Computed Tomography Angiography Protocol A 128-section multidetector CT (Philips brillianceiCT was used for scanning with the following scanning parameters，tube voltage was 120 kVp, tube current 40-440mA, and 0.625-mm slice thicknesses. The protocols required patients to lie supine with legs extended, A fixed bolus of contrast medium with total volume of 90 ml (370 mg iodine per milliliter) was injected into antecubital vein at a rate of 4 mL/sec, followed by a 30 mL saline flush, by using a dual-barrel power injector. CT scanning was performed with the coverage from the common iliac artery bifurcation to the tiptoe. Scanning began 12 seconds after an attenuation threshold of 150 HU was reached.
CTA Data Analysis CTA data were transferred to an offline workstation for further analysis. Axial images, cross-sectional views, curved planar reformations (CPR), and multiplanar reformations (MPR), as well as three-dimensional maximum intensity projection images were available for evaluation. We measure the degree of transluminal calcification, CT attenuation value of the proximal occlusion ,anatomic distribution of the leision,and length of occlusion,and the degree of stenosis CTO Crossing Strategy CTO crossing strategy was wire-catheter. Technical success was defined as crossing the CTO and placement of a guidewire in the distal true lumen confirmed by angiography.Outcomes include binary variables of lesion crossing described as technical success or failure.
Follow-up We also examined patient adverse events after procedures at 12 months: all-cause death,nonfatal myocardial infarction,revascularization and amputation.
Built prediction model we can establish model with preoperative computer tomography angiography that provided the lesion detail characteristic combing the patients' biochemical and clinical feature to predict the procedural and long-term outcomes of endovascular revascularization for Lower extremity peripheral artery chronic total occlusions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| technical success group | – | –Technical success was defined as crossing the CTO and placement of a guidewire in the distal true lumen confirmed by angiography. |
| technical failure group | – | –Technical failure was defined that guidewire could not crossing through the CTO nor reture to the true lumen by angiography. |
| had adverse events group | – | –Patients had one of the adverse events such as all-cause death, nonfatal myocardial infarction, repeat revascularization or amputation.at 12 months after procedures. |
| had no adverse events group | – | –Patients had none adverse events such as all-cause death, nonfatal myocardial infarction, repeat revascularization and amputation at 12 months after procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PAD patients with CTOs confirmed by angiograpy underwent pre-procedue CTA and endovascular revascularization
Key inclusion criteria (1 listed)
- PAD patients with CTOs confirmed by angiograpy underwent pre-procedue CTA and endovascular revascularization
Key exclusion criteria (1 listed)
- Patients' clinical date were incomplete; The interval between preprocedural CTA and PTA. was more than one month The CTA images could not be evaluated because of motion and metal artifact Loss to follow-up
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
technical success
Time frame: At time of procedure (day 0)
Successful crossing the CTO and placement of a guidewire in the distal true lumen confirmed by angiography
1 secondary outcome
Composite of Major Adverse Events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
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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.
Jian Yang, archiater principal investigator
First Affiliated Hospital Xi'an Jiaotong University
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 Artery Disease, run by First Affiliated Hospital Xi'an Jiaotong 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 1 inclusion and 1 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 8 Nov 2018. 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 Ningning Ding, visiting staff (0086-18092708665, dingningning1985@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical success (time frame: At time of procedure (day 0)). 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 8 Nov 2018.