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Peripheral Arterial DiseaseNCT06014242

Peripheral Microvascular Resistance as a Predictor for Limb Salvage

A study testing Peripheral vascular flow reserve measurement in people with Peripheral Arterial Disease, run by Hackensack Meridian Health.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Salvaging a threatened limb is the key therapeutic objective for patients with critical limb ischemia, and the achievement of limb salvage is an independent predictor of patient morbidity and mortality. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
Peripheral vascular flow reserve measurement
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
15 Sep 2025to 15 Sep 2026
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic critical limb ischemia (Rutherford 4-6).
  • Age ≥18 years
  • Ability and willingness to sign the IRB approved Informed Consent form

Who cannot join

  • Non-reconstructable chronic total occlusive disease of the proximal inflow vessels that would make flow reserve measurements impossible.
  • Non-salvageable lower extremity due to infection or overwhelming per-existing tissue loss (most critical Rutherford 6 patients).
  • Inability to understand the study or a history of non-compliance with medical advice;
  • History of any cognitive or mental health status that would interfere with study participation;
  • Currently enrolled in any pre-approval investigational study.
  • Female subjects who are pregnant or nursing or planning to become pregnant within the study period;
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  • Known sensitivity to contrast media, which can't be adequately pre-medicated;
  • Expected life span less than 6 months.
  • Unable to read/understand/sign the English Language consent form

About this study

Official title: Peripheral Microvascular Resistance as a Predictor for Limb Salvage in Post-Intervention Critical Limb Ischemia Patients

Salvaging a threatened limb is the key therapeutic objective for patients with critical limb ischemia, and the achievement of limb salvage is an independent predictor of patient morbidity and mortality. Despite successful primary endovascular or surgical intervention, the corresponding symptoms of rest pain and/or non-healing ulceration in some patients may continue, and amputation in these patients is unavoidable. It is hypothesized that the functional integrity of the peripheral vascular microcirculation may be impaired in these patients. However, there are currently no techniques that allow direct quantification and visualization of the microcirculation due to the micro-vessel invisibility under angiography.

In the coronary circulation, coronary flow reserve (CFR) indicates the capacity for maximal hyperemic blood flow and reveals impaired coronary microvascular function. Studies have shown the clinical significance of measuring microvascular resistance to predict myocardial salvage after myocardial infarction. The study will explore whether this concept of coronary flow reserve can be applied peripherally to patients with critical limb ischemia in order to determine whether measuring peripheral vascular flow reserve can determine the integrity of the microcirculation to predict limb salvage after endovascular intervention.

Being tested
Peripheral vascular flow reserve measurement
Keywords
Microvascular disease, Microvascular Resistance, Limb Salvage, Peripheral Arterial Disease, critical limb ischemia
Medical subject headings
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peripheral vascular flow reserve measurementDiagnostic test

    Peripheral arterial (below knee popliteal and above the level of ankle distal tibial) thermodilution curves will be obtained. One of the distal tibial arteries (anterior tibial, posterior tibial or peroneal artery, whichever reaches the most distal part of the foot in the run off) will be picked for measurements. At room temperature, 3 ml of saline will be injected brisk manually to determine the peak arterial flow, presented as mean transit time (Tmn). Resting Tmn will be performed and averaged by triplicate measurements at baseline. Then maximal hyperemia will be induced by intra-arterial injection of 30 mg papaverine through the guiding catheter, then 3 ml of saline will be injected to get hyperemic Tmn averaged by triplicate measurements. The guidewire will be kept in a fixed position during the series of measurements. Peripheral vascular flow reserve was calculated as resting Tmn divided by hyperemic Tmn (Fukunaga 2015).

Study groups in NCT06014242
Study groupRoleWhat they receive
Peripheral vascular flow reserve measurementExperimentalPost-procedure peripheral vascular flow reserve by thermodilution will be measured by the pressure wire.
Receives: Diagnostic Test: Peripheral vascular flow reserve measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of the peripheral flow reserve

    To assess whether peripheral flow reserve can predict the success rate of limb salvage in critical limb ischemia patients after endovascular intervention. Assessed by any amputation (major or minor) at 6 months post-endovascular intervention.

    Measured: 6 months post-endovascular intervention

Secondary outcomes (14)

  1. Symptom resolution - Ulcer healing (1m)

    Ulcer healing: changes in the number and extent of leg ulcers compared to baseline.

    Measured: 1 month post-endovascular intervention

  2. Symptom resolution - Ulcer healing (6m)

    Ulcer healing: changes in the number and extent of leg ulcers compared to baseline.

    Measured: 6 months post-endovascular intervention

  3. Number of patients with Symptom resolution - Pain (1m)

    Resolution of rest pain and alteration in visual analogue pain compared to baseline.

    Measured: 1 month post-endovascular intervention

  4. Number of patients with Symptom resolution - Pain (6m)

    Resolution of rest pain and alteration in visual analogue pain compared to baseline.

    Measured: 6 months post-endovascular intervention

  5. Ankle-brachial index (ABI) (1m)

    Improvement in Ankle-brachial index (ABI) compared to baseline. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. Normal ABI ranges from 1.0 - 1.4, with <0.9 suggesting arterial disease.

    Measured: 1 month post-endovascular intervention

  6. Ankle-brachial index (ABI) (6m)

    Improvement in Ankle-brachial index (ABI) compared to baseline. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. Normal ABI ranges from 1.0 - 1.4, with <0.9 suggesting arterial disease.

    Measured: 6 months post-endovascular intervention

  7. Toe-brachial index (TBI) (1m)

    Improvement in Toe-brachial index (TBI) compared to baseline. The Toe Brachial Index (TBI) is defined as the ratio between the systolic blood pressure in the right or left toe and the higher of the systolic pressure in the right or left arms. TBI ≥ 0.7 is considered normal while TBI < 0.7 is considered abnormal.

    Measured: 1 month post-endovascular intervention

  8. Toe-brachial index (TBI) (6m)

    Improvement in Toe-brachial index (TBI) compared to baseline. The Toe Brachial Index (TBI) is defined as the ratio between the systolic blood pressure in the right or left toe and the higher of the systolic pressure in the right or left arms. TBI ≥ 0.7 is considered normal while TBI < 0.7 is considered abnormal.

    Measured: 6 months post-endovascular intervention

  9. Rutherford classification (1m)

    Use of The Rutherford classification to assess peripheral artery disease compared to baseline. A 7 category scale is being used with 0 being Asymptomatic and 6 being Ulceration or gangrene.

    Measured: 1 month post-endovascular intervention

  10. Rutherford classification (6m)

    Use of The Rutherford classification to assess peripheral artery disease compared to baseline. A 7 category scale is being used with 0 being Asymptomatic and 6 being Ulceration or gangrene.

    Measured: 6 months post-endovascular intervention

  11. Transcutaneous oxygen partial pressure (TcPO2) (1m)

    Transcutaneous partial pressure of oxygen (TcPO2) will be measured representing the amount of oxygen diffusing outward across the skin (used as a surrogate for arterial perfusion).

    Measured: 1 month post-endovascular intervention

  12. Transcutaneous oxygen partial pressure (TcPO2) (6m)

    Transcutaneous partial pressure of oxygen (TcPO2) will be measured representing the amount of oxygen diffusing outward across the skin (used as a surrogate for arterial perfusion).

    Measured: 6 months post-endovascular intervention

  13. Target lesion revascularization (1m)

    Need for revascularization (yes/no)

    Measured: At 1 month post-endovascular intervention

  14. Target lesion revascularization (6m)

    Need for revascularization (yes/no)

    Measured: At 6 month post-endovascular intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion15 Sep 2026 (estimated)
  4. Study completion15 Sep 2026 (estimated)

Why it stopped: Study was never opened to enrollment

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06014242
Sponsor's protocol ID
Pro2021-0681
Status last verified
Sep 2025
First submitted
21 Aug 2023
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • McGinn, A.L., White, C.W. and Wilson, R.F., 1990. Interstudy variability of coronary flow reserve. Influence of heart rate, arterial pressure, and ventricular preload. Circulation, 81(4), pp.1319-1330. Nahser Jr, P.J., Brown, R.E., Oskarsson, H., Winniford, M.D. and Rossen, J.D., 1995. Maximal coronary flow reserve and metabolic coronary vasodilation in patients with diabetes mellitus. Circulation, 91(3), pp.635-640. Payne, A.R., Berry, C., Doolin, O., McEntegart, M., Petrie, M.C., Lindsay, M.M., Hood, S., Carrick, D., Tzemos, N., Weale, P. and McComb, C., 2012. Microvascular resistance predicts myocardial salvage and infarct characteristics in ST-elevation myocardial infarction. Journal of the American Heart Association, 1(4), p.e002246. Camici, P.G., d'Amati, G. and Rimoldi, O., 2015. Coronary microvascular dysfunction: mechanisms and functional assessment. Nature Reviews Cardiology, 12(1), p.48.

  • Fukunaga M, Fujii K, Kawasaki D, Nishimura M, Horimatsu T, Saita T, Miki K, Tamaru H, Imanaka T, Naito Y, Masuyama T. Vascular flow reserve immediately after infrapopliteal intervention as a predictor of wound healing in patients with foot tissue loss. Circ Cardiovasc Interv. 2015 Jun;8(6):e002412. doi: 10.1161/CIRCINTERVENTIONS.115.002412.

    PubMed 26019143

  • Crea, F., Lanza, G.A. and Camici, P.G., 2014. Mechanisms of coronary microvascular dysfunction. In Coronary Microvascular Dysfunction (pp. 31-47). Springer, Milano.

  • Pijls NH, De Bruyne B, Smith L, Aarnoudse W, Barbato E, Bartunek J, Bech GJ, Van De Vosse F. Coronary thermodilution to assess flow reserve: validation in humans. Circulation. 2002 May 28;105(21):2482-6. doi: 10.1161/01.cir.0000017199.09457.3d.

    PubMed 12034653

  • Kern MJ. Coronary physiology revisited : practical insights from the cardiac catheterization laboratory. Circulation. 2000 Mar 21;101(11):1344-51. doi: 10.1161/01.cir.101.11.1344.

    PubMed 10725297

Questions about this trial

What is this clinical trial studying?

A study testing Peripheral vascular flow reserve measurement in people with Peripheral Arterial Disease, run by Hackensack Meridian Health.

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 3 inclusion and 9 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 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

Efficacy of the peripheral flow reserve (time frame: 6 months post-endovascular intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06014242, which also lists 5 linked publications.

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 24 Sep 2025.

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