Predicting Procedural and Long-term Outcomes of Endovascular Revascularization for Lower Extremity Peripheral Artery Chronic Total Occlusions With Computed Tomographic Angiography

NCT03734549 | Unknown

• 1 other identifier: XJTUAF2017LSK-137
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• technical success

  Successful crossing the CTO and placement of a guidewire in the distal true lumen confirmed by angiography

  At time of procedure (day 0)

Secondary Outcomes (1)

• Composite of Major Adverse Events

  12 months

Study Arms (4)

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

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 with CTOs confirmed by angiograpy underwent pre-procedue CTA and endovascular revascularization

You may qualify if:

• PAD patients with CTOs confirmed by angiograpy underwent pre-procedue CTA and endovascular revascularization

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

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, archiater

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ningning Ding, visiting staff

CONTACT

0086-18092708665; dingningning1985@126.com

Study Design

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

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: November 8, 2018
• Study Start: December 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 8, 2018

Record last verified: 2018-06

Locations

CN (1)