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

Diagnosis and Treatment of Coronary Artery Disease in Severe Peripheral Artery Disease After Lower Extremity Revascularization

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Peripheral Artery Disease
• Intervention / Treatment: Diagnostic test: Coronary computed topography (CT) angiography with FFR-CT

Detailed Description

This study will be to conduct a randomized, controlled, multi-center clinical trial to evaluate a non-invasive management strategy of a computed topography (CT) scan of the coronary arteries and computational analysis of coronary perfusion with selective coronary revascularization plus optimal medical therapy compared to optimal medical therapy. Therefore, this study will provide the opportunity for Veterans to participate in a clinical trial to reduce the very high cardiac-related mortality rate in this population.

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clay Quint, MD PhD; Phone Number: (210) 606-2940; Email: clay.quint@va.gov

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center, Aurora, CO
      • Contact: Clay Quint, MD PhD; Phone Number: 210-606-2940; Email: clay.quint@va.gov
      • Principal Investigator: Clay Quint, MD PhD
  • Florida
    • Gainesville, Florida, United States, 32608-1135
      • North Florida/South Georgia Veterans Health System, Gainesville, FL
      • Contact: Salvatore Scali, MD; Phone Number: 352-376-1611
  • Ohio
    • Cleveland, Ohio, United States, 44106-1702
      • Louis Stokes VA Medical Center, Cleveland, OH
      • Contact: Michael Rosenbaum, MD; Phone Number: 216-791-3800
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
      • Contact: Edith Tzeng, MD; Phone Number: 866-482-7488
  • Tennessee
    • Nashville, Tennessee, United States, 37212-2637
      • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
      • Contact: John Curci, MD; Phone Number: 615-327-4751
  • Texas
    • Dallas, Texas, United States, 75216-7167
      • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
      • Contact: Shirling Tsai, MD; Phone Number: 469-797-2100
  • Washington
    • Seattle, Washington, United States, 98108-1532
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA
      • Contact: Gale Tang, MD; Phone Number: 800-329-8387

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Treatment Strategy; 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; The investigational treatment strategy will have a coronary CT angiography diagnostic imaging with computational analysis FFR-CT (Fractional Flow Reserve from the coronary CTA)
No Intervention: Standard; This arm will have optimal medical therapy after lower extremity revascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events (MACE)	cardiovascular-related death or myocardial infarction	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular-related death	death related to cardiovascular disease (i.e., heart attack)	2 years
Myocardioal infarction	heart attack	2 years
All-cause mortality	death related to any cause	2 years
Amputation-free survival	freedom from major amputation	2 years

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Clay Quint, MD PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Peripheral Arterial Disease
• Other Study ID Numbers: SURG-006-23S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The overall data will be shared and reported, but not individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No