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

NCT05570019 | Recruiting

• 1 other identifier: 1440/2021
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 revascularization procedures (open surgery and/or angioplasty).

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Critical Limb Ischemia

Keywords

Tissue perfusion; Peripheral arterial disease; Critical limb threatening ischemia; Critical limb ischemia; Fluorescence angiography; Fluorescence imaging; Indocyanine green; Microcirculation

Outcome Measures

Primary Outcomes (1)

• Transcutaneous oxygen pressure

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

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

Secondary Outcomes (8)

• WIfI stage

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

• Rutherford category

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

• Primary patency

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

• Secondary patency

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

• Limb salvage

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

Interventions

Revascularization PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Department of Vascular Surgery, Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Related Publications (3)

• 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.

  PMID: 29579461 BACKGROUND

• 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.

  PMID: 31182334 BACKGROUND

• 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.

  PMID: 9308598 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Florian K Enzmann, MD, PhD

CONTACT

004343512504; florian.enzmann@i-med.ac.at

Michaela Kluckner, MD

CONTACT

004343512504; michaela.kluckner@i-med.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: October 6, 2022
• Study Start: October 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)