Predicting Outcomes of PAD Patients Undergoing Endovascular Intervention With CTA

NCT03974880 | Unknown

• 1 other identifier: XJTU1AF2019LSY-16
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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

  at 1,3,6,12 moth

• re-intervention group

  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 Outcomes (3)

• amputation

  at 1,3,6,12 moth

• Co-morbid cardio-cerebral vascular diseases

  at 1,3,6,12 moth

• neo- segment lesion

  at 1,3,6,12 moth

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Subject's age ≥ 18 years.
• Subject presents with a Fontaine classification of 2 to 5;
• 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.

You may not qualify if:

• Subject is unwilling or unable to sign the informed consent form.
• Subject is unable to understand or comply with the study protocol requirements.
• Subject has been performed a surgical bypass graft for any lesion(s) in the target area or amputation as determined by the Investigator.
• Subject has a history of malignant tumor.
• 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.
• Subject has the contraindications to CTA or DSA.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Jian Yang, MD,PhD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhou, MD

CONTACT

0086-17791633960; zhouli222729@126.com

Jian Yang, MD,PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: July 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)