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

Coronary Artery Disease Clinical Trial

— CAD in sPAD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06387355
• Other study ID #: SURG-006-23S
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: August 1, 2029

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Clay Quint, MD PhD
• Phone: (210) 606-2940
• Email: clay.quint[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: August 1, 2029
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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)

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio
United States	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas
United States	North Florida/South Georgia Veterans Health System, Gainesville, FL	Gainesville	Florida
United States	Tennessee Valley Healthcare System Nashville Campus, Nashville, TN	Nashville	Tennessee
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events (MACE)	cardiovascular-related death or myocardial infarction	2 years
Secondary	Cardiovascular-related death	death related to cardiovascular disease (i.e., heart attack)	2 years
Secondary	Myocardioal infarction	heart attack	2 years
Secondary	All-cause mortality	death related to any cause	2 years
Secondary	Amputation-free survival	freedom from major amputation	2 years