Lower extremity peripheral artery disease (PAD), the third leading cause of atherosclerotic cardiovascular morbidity following coronary artery disease and stroke, affect 200 million people worldwide and is associated with high rates of cardiovascular events and death. Consensus is reached on an "endovascular-first-strategy" for symptomatic PAD who have developed critical limb ischemia.
However, the challenge of endovascular therapy is the long-term patency, and the associated worse clinical outcomes, including higher rates of major adverse cardiovascular events, and major adverse limb events. Meta-analysis concluded that restenosis occurred rate 5-70 % at 1 year; the incidence of adverse limb outcomes, (including worsening of symptoms, the need for peripheral revascularization, and amputation) was 26% over a period of 4 years; Cardiovascular morbidity and mortality up to 28 % after endovascular therapy.
There are no consensus guidelines on the optimal timing and the factor on adverse clinical outcome remains uncertain. Therefore, the purpose of this study is to conduct a structured surveillance plan for follow-up care and evaluate risk factors that will eventually support development of a predictive model for clinical outcomes of endovascular procedures to treat lower extremity PAD.
Condition or disease |
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Peripheral Artery Disease |
This is a prospective, observational, multi-center, clinical study examining predictors of clinical outcomes for patients undergoing PAD endovascular treatment. The study population will undergo lower extremity computed tomographic angiography (CTA )and endovascular intervention procedures. CT scanning was performed with the coverage from the common iliac artery bifurcation to the tiptoe, CTA data were transfer to an offline workstation for further analysis. Axial images, cross-sectional views, curved planar reformations and multiplane reformations, as well as three dimensional maximum intensity projection images were available for evaluation. This includes disease in a vessel located proximal(involving the aortoiliac and femoropopliteal locations), distal, (involving the infrapopliteal location), proximal and distal (multilevel disease).
We conduct a detailed chart review to gather the data related to the index endovascular intervention procedures report, study personnel history and physical presentation, laboratory inspection, the lesion characteristics arising from CTA. Data abstract from chart review include indication for procedure (intermittent claudication, rest pain, and tissue loss), detailed lesion characteristics (lesion length, stenosis severity, diameter, and presence of total occlusion), procedure(s) performed and devices used, and per procedural events.
Patients will be followed up for the occurrence of these outcomes from the time of their initial revascularization procedure(1month after enrollment, and at months 3 (+- 2 weeks), 6 (+- 2 weeks), and 12 (+- 2 weeks)).
The follow-up of Clinical outcomes : Primary clinical outcomes of interest were :1)restenosis in the treated segment(Restenosis was defined as a reduction in the luminal diameter of more than 50 percent according to any imaging examinations such as duplex ultrasound, CTA,magnetic resonance Imaging(MRI) or digital subtraction angiography(DSA) );2)re-intervention in the treated segment for the clinical progression. Secondary end points included:1) all lower extremity amputation, 2) all -cause death, myocardial infarction, and stroke; 3) a neo- segment more than 75 % stenosis and clinical assessment requires intervention .
Cox proportional hazards models were created to show the hazard ratios (HRs) associated with lesion characters and patient demographic and clinical characteristics ,and further identify predictors of clinical outcomes, moreover, plotted unadjusted Kaplan Meier curves for lower extremity peripheral artery patients undergone endovascular revascularization.
Study Type : | Observational |
Estimated Enrollment : | 480 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Predicting the Clinical Outcomes of Patients With Lower Extremity Peripheral Arterial Disease Undergoing Endovascular Intervention Based on Computed Tomographic Angiography |
Estimated Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | January 2022 |
Estimated Study Completion Date : | December 2022 |
Group/Cohort |
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patency group
Freedom from restenosis or clinically driven re-intervention in the treated lesion at 1,3,6,12 months after procedures
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restenosis group
Restenosis was defined as a reduction in the luminal diameter of more than 50 percent according to any imaging examinations such as duplex ultrasound, CTA, MRI or DSA Re-intervention in the treated segment for the clinical progression at 1,3,6,12 months after procedures
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the second adverse events group
a composite of all-cause death, myocardial infarction, and stroke and any amputation at 1,3,6,12 months after procedures
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
If subject presents with bilateral disease, the first limb treated with a lesion in the target area will be considered the target limb.
Exclusion Criteria:
Contact: Li Zhou, MD | 0086-17791633960 | zhouli222729@126.com | |
Contact: Jian Yang, MD,PhD |
China, Shaanxi | |
First Affiliated Hospital of Xi'an Jiaotong University | |
Xi'an, Shaanxi, China | |
Contact: Jian Yang, Ph.D.,M.D. +8618991232396 cjr.yangjian@vip.163.com |
Principal Investigator: | Jian Yang, MD,PhD | First Affiliated Hospital Xi'an Jiaotong University |
Tracking Information | |||||||||
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First Submitted Date | June 3, 2019 | ||||||||
First Posted Date | June 5, 2019 | ||||||||
Last Update Posted Date | June 5, 2019 | ||||||||
Estimated Study Start Date | July 1, 2019 | ||||||||
Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Predicting Outcomes of PAD Patients Undergoing Endovascular Intervention With CTA | ||||||||
Official Title | Predicting the Clinical Outcomes of Patients With Lower Extremity Peripheral Arterial Disease Undergoing Endovascular Intervention Based on Computed Tomographic Angiography | ||||||||
Brief Summary |
Lower extremity peripheral artery disease (PAD), the third leading cause of atherosclerotic cardiovascular morbidity following coronary artery disease and stroke, affect 200 million people worldwide and is associated with high rates of cardiovascular events and death. Consensus is reached on an "endovascular-first-strategy" for symptomatic PAD who have developed critical limb ischemia. However, the challenge of endovascular therapy is the long-term patency, and the associated worse clinical outcomes, including higher rates of major adverse cardiovascular events, and major adverse limb events. Meta-analysis concluded that restenosis occurred rate 5-70 % at 1 year; the incidence of adverse limb outcomes, (including worsening of symptoms, the need for peripheral revascularization, and amputation) was 26% over a period of 4 years; Cardiovascular morbidity and mortality up to 28 % after endovascular therapy. There are no consensus guidelines on the optimal timing and the factor on adverse clinical outcome remains uncertain. Therefore, the purpose of this study is to conduct a structured surveillance plan for follow-up care and evaluate risk factors that will eventually support development of a predictive model for clinical outcomes of endovascular procedures to treat lower extremity PAD. |
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Detailed Description |
This is a prospective, observational, multi-center, clinical study examining predictors of clinical outcomes for patients undergoing PAD endovascular treatment. The study population will undergo lower extremity computed tomographic angiography (CTA )and endovascular intervention procedures. CT scanning was performed with the coverage from the common iliac artery bifurcation to the tiptoe, CTA data were transfer to an offline workstation for further analysis. Axial images, cross-sectional views, curved planar reformations and multiplane reformations, as well as three dimensional maximum intensity projection images were available for evaluation. This includes disease in a vessel located proximal(involving the aortoiliac and femoropopliteal locations), distal, (involving the infrapopliteal location), proximal and distal (multilevel disease). We conduct a detailed chart review to gather the data related to the index endovascular intervention procedures report, study personnel history and physical presentation, laboratory inspection, the lesion characteristics arising from CTA. Data abstract from chart review include indication for procedure (intermittent claudication, rest pain, and tissue loss), detailed lesion characteristics (lesion length, stenosis severity, diameter, and presence of total occlusion), procedure(s) performed and devices used, and per procedural events. Patients will be followed up for the occurrence of these outcomes from the time of their initial revascularization procedure(1month after enrollment, and at months 3 (+- 2 weeks), 6 (+- 2 weeks), and 12 (+- 2 weeks)). The follow-up of Clinical outcomes : Primary clinical outcomes of interest were :1)restenosis in the treated segment(Restenosis was defined as a reduction in the luminal diameter of more than 50 percent according to any imaging examinations such as duplex ultrasound, CTA,magnetic resonance Imaging(MRI) or digital subtraction angiography(DSA) );2)re-intervention in the treated segment for the clinical progression. Secondary end points included:1) all lower extremity amputation, 2) all -cause death, myocardial infarction, and stroke; 3) a neo- segment more than 75 % stenosis and clinical assessment requires intervention . Cox proportional hazards models were created to show the hazard ratios (HRs) associated with lesion characters and patient demographic and clinical characteristics ,and further identify predictors of clinical outcomes, moreover, plotted unadjusted Kaplan Meier curves for lower extremity peripheral artery patients undergone endovascular revascularization. |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Probability Sample | ||||||||
Study Population | PAD patients met the inclusion criteria underwent pre-procedue CTA and endovascular revascularization | ||||||||
Condition | Peripheral Artery Disease | ||||||||
Intervention | Not Provided | ||||||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Not yet recruiting | ||||||||
Estimated Enrollment |
480 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | December 2022 | ||||||||
Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
If subject presents with bilateral disease, the first limb treated with a lesion in the target area will be considered the target limb. Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03974880 | ||||||||
Other Study ID Numbers | XJTU1AF2019LSY-16 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | First Affiliated Hospital Xi'an Jiaotong University | ||||||||
Study Sponsor | First Affiliated Hospital Xi'an Jiaotong University | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | First Affiliated Hospital Xi'an Jiaotong University | ||||||||
Verification Date | June 2019 |