Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization

NCT06387355 | Withdrawn DMC

• 1 other identifier: SURG-006-23S
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

Peripheral artery disease, lack or blood flow to the legs, has a high prevalence in the Veteran population. In patients with severe peripheral artery disease that requires an endovascular or surgical intervention for lower leg revascularization, the long-term mortality of approximately 50% is worse that most cancers. The goal of this study is to develop a management strategy to improve cardiovascular outcomes in this high-risk peripheral artery disease population after lower extremity revascularization.

Conditions

Peripheral Artery Disease; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events (MACE)

  cardiovascular-related death or myocardial infarction

  2 years

Secondary Outcomes (4)

• Cardiovascular-related death

  2 years

• Myocardioal infarction

  2 years

• All-cause mortality

  2 years

• Amputation-free survival

  2 years

Study Arms (2)

Investigational Treatment Strategy

EXPERIMENTAL

This arm will have a coronary CTA with FFR-CT with selective coronary artery revascularization plus optimal medical therapy after lower extremity revascularization

Diagnostic Test: Coronary computed topography (CT) angiography with FFR-CT

Standard

NO INTERVENTION

This arm will have optimal medical therapy after lower extremity revascularization

Interventions

Coronary computed topography (CT) angiography with FFR-CT DIAGNOSTIC_TEST

The investigational treatment strategy will have a coronary CT angiography diagnostic imaging with computational analysis FFR-CT (Fractional Flow Reserve from the coronary CTA)

Investigational Treatment Strategy

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 50 to 85
• Severe intermittent claudication with ABI \< 0.6 or monophasic waveform if non-compressible and TBI \< 0.6
• Chronic limb threatening ischemia (CLTI) with pain at rest (Rutherford Category 4) with ABI \< 0.5 or TBI \< 0.6
• CLTI with minor tissue loss (Rutherford Category 5) with ABI \< 0.5 or TBI \< 0.6
• Completed Lower Extremity Revascularization and enrolled within 45 days
• The patient or legal representative will provide informed written consent
• The patient has a life expectancy of at least 1 year

You may not qualify if:

• Major tissue loss of the ischemic limb (Rutherford Category 6)
• Uncompensated congestive heart failure (NYHA class IV)
• Myocardial infarction or stroke within the past 90 days
• Prior coronary artery bypass graft (CABG) revascularization surgery
• Prior percutaneous coronary intervention (PCI) with angioplasty or stenting
• Presence of a pacemaker
• Congestive heart failure with Ejection Fraction \< 30%
• Elevated liver function tests more than twice the upper limit of normal
• Severe Chronic renal disease (Glomerular Filtration Rate, GFR \< 30) or on hemodialysis
• Pregnancy, Human Immunodeficiency Virus, or organ transplant recipients
• Current malignancy or malignancy within the last two years unless the treating oncologic physician provides prognosis of an anticipated 2- year survival (i.e., adequately treated non-melanoma skin cancer or adequately treated prostate cancer without metastatic disease)
• Any condition the review panel determines would make the patient unsuitable for participation in the study

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (7)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608-1135, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216-7167, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Coronary Artery Disease

Interventions

Angiography

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular

Study Officials

• Clay Quint, MD PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This will be a parallel interventional model to assign participants to a treatment strategy in a clinical study

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 29, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)