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Predicting Outcomes of PAD Patients Undergoing Endovascular Intervention With CTA

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ClinicalTrials.gov Identifier: NCT03974880
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.


Condition or disease
Peripheral Artery Disease

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
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

Resource links provided by the National Library of Medicine


Group/Cohort
patency group
Freedom from restenosis or clinically driven re-intervention in the treated lesion at 1,3,6,12 months after procedures
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
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



Primary Outcome Measures :
  1. restenosis group [ Time Frame: at 1,3,6,12 moth ]
    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

  2. re-intervention group [ Time Frame: at 1,3,6,12 moth ]
    re-intervention in the treated segment for the clinical progression, but a reduction in the luminal diameter of low than 50 percent according to any imaging examinations.


Secondary Outcome Measures :
  1. amputation [ Time Frame: at 1,3,6,12 moth ]
    all lower extremity amputation

  2. Co-morbid cardio-cerebral vascular diseases [ Time Frame: at 1,3,6,12 moth ]
    Co-morbid cardio-cerebral vascular diseases include all -cause death, myocardial infarction, and stroke

  3. neo- segment lesion [ Time Frame: at 1,3,6,12 moth ]
    a neo- segment lesion is more than 75 % stenosis and clinical assessment requires intervention



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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
Study Population
PAD patients met the inclusion criteria underwent pre-procedue CTA and endovascular revascularization
Criteria

Inclusion Criteria:

  1. Subject's age ≥ 18 years.
  2. Subject presents with a Fontaine classification of 2 to 5;
  3. Subject presents with clinical evidence of PAD requiring endovascular intervention on one or both limbs that includes a target lesion, and never undergo endovascular intervention on any limb.

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:

  1. Subject is unwilling or unable to sign the informed consent form.
  2. Subject is unable to understand or comply with the study protocol requirements.
  3. Subject has been performed a surgical bypass graft for any lesion(s) in the target area or amputation as determined by the Investigator.
  4. Subject has a history of malignant tumor.
  5. The interval between CTA and endovascular intervention is more than 1 month and the CTA images could not be evaluated because of motion and metal artifact.
  6. Subject has the contraindications to CTA or DSA.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974880


Contacts
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Contact: Li Zhou, MD 0086-17791633960 zhouli222729@126.com
Contact: Jian Yang, MD,PhD

Locations
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China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Not yet recruiting
Xi'an, Shaanxi, China
Contact: Jian Yang, Ph.D.,M.D.    +8618991232396    cjr.yangjian@vip.163.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Principal Investigator: Jian Yang, MD,PhD First Affiliated Hospital Xi'an Jiaotong University

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03974880     History of Changes
Other Study ID Numbers: XJTU1AF2019LSY-16
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases