Peripheral Artery DiseaseCAD in sPADNCT06387355
Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization
A study testing Coronary computed topography (CT) angiography with FFR-CT in people with Peripheral Artery Disease and Coronary Artery Disease, run by VA Office of Research and Development at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Peripheral Artery Disease, Coronary Artery Disease
- What is being tested?
- Coronary computed topography (CT) angiography with FFR-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Nov 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Artery Disease, Coronary Artery Disease
- Being tested
- Coronary computed topography (CT) angiography with FFR-CT
- Medical subject headings
- Peripheral Arterial Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary computed topography (CT) angiography with FFR-CTDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Coronary computed topography (CT) angiography with FFR-CT |
| Standard | No intervention | This arm will have optimal medical therapy after lower extremity revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
cardiovascular-related death or myocardial infarction
Measured: 2 years
Secondary outcomes (4)
Cardiovascular-related death
death related to cardiovascular disease (i.e., heart attack)
Measured: 2 years
Myocardioal infarction
heart attack
Measured: 2 years
All-cause mortality
death related to any cause
Measured: 2 years
Amputation-free survival
freedom from major amputation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Why it stopped: Intent to fund was rescinded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a parallel interventional model to assign participants to a treatment strategy in a clinical study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Clay Quint, MD PhD, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387355
- Sponsor's protocol ID
- SURG-006-23S
- Acronym
- CAD in sPAD
- Status last verified
- Sep 2025
- First submitted
- 22 Apr 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The overall data will be shared and reported, but not individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Treatment of Coronary Artery Disease in Severe Peripheral Artery Disease After Lower Extremity Revascularization
- ClinicalTrials.gov ID
- NCT06387355
- Acronym / sponsor ID
- CAD in sPAD / SURG-006-23S
- Conditions
- Peripheral Artery Disease, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Intent to fund was rescinded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a parallel interventional model to assign participants to a treatment strategy in a clinical study
| Arm | Type | Receives |
|---|---|---|
| Investigational Treatment Strategy | Experimental | Diagnostic Test: Coronary computed topography (CT) angiography with FFR-CTThis arm will have a coronary CTA with FFR-CT with selective coronary artery revascularization plus optimal medical therapy after lower extremity revascularization |
| Standard | No intervention | –This arm will have optimal medical therapy after lower extremity revascularization |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary computed topography (CT) angiography with FFR-CTThe investigational treatment strategy will have a coronary CT angiography diagnostic imaging with computational analysis FFR-CT (Fractional Flow Reserve from the coronary CTA) | Diagnostic test | Investigational Treatment Strategy |
Primary outcome
Major adverse cardiovascular events (MACE)
Time frame: 2 years
cardiovascular-related death or myocardial infarction
4 secondary outcomes
Cardiovascular-related death
Time frame: 2 years
Myocardioal infarction
Time frame: 2 years
All-cause mortality
Time frame: 2 years
Amputation-free survival
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No. The overall data will be shared and reported, but not individual participant data.
Related trials for Peripheral Artery Disease
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The THOR IDE Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clay Quint, MD PhD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary computed topography (CT) angiography with FFR-CT in people with Peripheral Artery Disease and Coronary Artery Disease, run by VA Office of Research and Development at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.