Predicting Outcomes of PAD Patients Undergoing Endovascular Intervention With CTA

June 3, 2019 updated by: First Affiliated Hospital Xi'an Jiaotong University

Predicting the Clinical Outcomes of Patients With Lower Extremity Peripheral Arterial Disease Undergoing Endovascular Intervention Based on Computed Tomographic Angiography

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jian Yang, MD,PhD

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 1,3,6,12 moth
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.
at 1,3,6,12 moth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amputation
Time Frame: at 1,3,6,12 moth
all lower extremity amputation
at 1,3,6,12 moth
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
at 1,3,6,12 moth
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
at 1,3,6,12 moth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Jian Yang, MD,PhD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 3, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2019LSY-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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