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Peripheral Arterial DiseaseEVTI-PADNCT05570019

Evaluation of Tissue Perfusion in Peripheral Arterial Disease (EVTI-PAD)

An observational study of Peripheral Arterial Disease and Chronic Limb-Threatening Ischemia, run by Medical University Innsbruck at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this prospective single-center observational study, arterial perfusion in patients with lower limb peripheral arterial disease will be assessed with standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Revascularization
Type of treatment
Surgery or procedure
How many people
200 participants
Where
1 siteAustria
Study dates
1 Oct 2022to 31 Dec 2024
Phase
Observational
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

Study population: Patients with symptomatic peripheral arterial disease (Rutherford categories 3-6) requiring revascularization procedures (open surgery and/or angioplasty).

Who may be able to join

  • patients with symptomatic peripheral arterial disease (Rutherford categories 3-6) requiring revascularization.

Who cannot join

  • patients younger than 18 years
  • patients unable to give consent without legal guardians
  • iodine allergy
  • hyperthyroidism
  • allergy to indocyanine green
  • Glomerular filtration rate <30ml/min/1.73m2

Trial locations and contacts

1 site in 1 country.

Florian K Enzmann, MD, PhD contact

004343512504 ext. 82196

florian.enzmann@i-med.ac.at

Michaela Kluckner, MD contact

004343512504 ext. 83496

michaela.kluckner@i-med.ac.at

Austria1 site, 1 recruiting

  • Department of Vascular Surgery, Medical University Innsbruck

    Innsbruck, Tyrol, 6020

    Florian Enzmann, MD, PhD, florian.enzmann@i-med.ac.at

    Recruiting

Other trials in Austria

About this study

Official title: Evaluation of Tissue Perfusion in Patients With Lower Extremity Peripheral Arterial Disease

In this prospective single-center observational study, arterial perfusion in patients with lower limb peripheral arterial disease will be assessed with standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures (open surgery and/or angioplasty).

Read the detailed description

Arterial perfusion is an important parameter for the capacity of wound healing in patients with peripheral arterial disease (PAD). Quantifying tissue perfusion in affected patients can help in deciding whether further revascularization is necessary to achieve wound healing and limb salvage. Not only in PAD patients with ulceration, but also in patients with rest pain or life-style limiting claudication, the measurement of arterial perfusion before and after revascularization could influence further treatment regarding surgical/interventional procedures as well as medical treatment. Digital subtraction angiography (DSA) is the gold standard for the evaluation of peripheral arterial outflow and for quality assessment after revascularization. However, angiography only displays the larger arteries and not tissue perfusion itself, which is crucial for wound healing. In this study, the change of tissue perfusion measured with the different standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures will be evaluated.

Being tested
Revascularization
Keywords
Tissue perfusion, Peripheral arterial disease, Critical limb threatening ischemia, Critical limb ischemia, Fluorescence angiography, Fluorescence imaging, Indocyanine green, Microcirculation
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.

  • RevascularizationProcedure or surgery

    Open surgery (arterial endarterectomy with or without bypass surgery) and/or angioplasty (with or without stent placement)

What is being measured

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

  1. Transcutaneous oxygen pressure

    Change in transcutaneous oxygen pressure is measured before and after the revascularization procedure.

    Measured: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure

Secondary outcomes (8)

  1. WIfI stage

    Change in WIfI (wound, ischemia, foot infection) stage is documented before and after the revascularization procedure.

    Measured: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure

  2. Rutherford category

    Change in Rutherford category is documented before and after the revascularization procedure.

    Measured: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure

  3. Primary patency

    Primary patency of the treated arterial lesion is documented after the procedure

    Measured: Post-procedural (within 5 days) and 3 months after the index procedure

  4. Secondary patency

    Secondary patency of the treated arterial lesion is documented after the procedure

    Measured: Post-procedural (within 5 days) and 3 months after the index procedure

  5. Limb salvage

    Limb salvage of the treated extremity is documented after the procedure

    Measured: Post-procedural (within 5 days) and 3 months after the index procedure

  6. Ankle-brachial index (ABI)

    Change in ABI is documented before and after the revascularization procedure.

    Measured: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure

  7. Fluorescence angiography

    Change in fluorescence angiography is documented before and after the revascularization procedure.

    Measured: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure

  8. Survival

    Survival of patients after the revascularization.

    Measured: Post-procedural (within 5 days) and 3 months after the index procedure

Timeline

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

  1. First posted6 Oct 2022
  2. Study start1 Oct 2022
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05570019
Sponsor's protocol ID
1440/2021
Acronym
EVTI-PAD
Status last verified
Mar 2024
First submitted
29 Aug 2022
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Halliday A, Bax JJ. The 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in Collaboration With the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Mar;55(3):301-302. doi: 10.1016/j.ejvs.2018.03.004. No abstract available.

    PubMed 29579461

  • Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfe N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8.

    PubMed 31182334

  • Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4.

    PubMed 9308598

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease and Chronic Limb-Threatening Ischemia, run by Medical University Innsbruck at 1 site in Austria.

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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Florian K Enzmann, MD, PhD (004343512504 ext. 82196, florian.enzmann@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transcutaneous oxygen pressure (time frame: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure). 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 NCT05570019, which also lists 3 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 13 Mar 2024.

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