NCT05360108

Brief Summary

Observational, prospective, cohort study to evaluate, by an opportunistic screening program based on vascular ultrasound, the prevalence and characteristics of Abdominal Aortic Aneurysm (AAA) and Popliteal Artery Aneurysm (PAA) in a female population as well as the prevalence and characteristics of PAA in male population.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
507

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jun 2020Jun 2029

Study Start

First participant enrolled

June 1, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2026

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Expected
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

April 26, 2022

Last Update Submit

March 12, 2026

Conditions

Popliteal Artery AneurysmAortic Aneurysm, Abdominal

Keywords

Abdominal aortic aneurysmPopliteal aneurysmScreening

Outcome Measures

Primary Outcomes (2)

  • Abdominal aortic measurement

    Ultrasound of infrarenal aorta with diameter measured in mm

    1 day

  • Popliteal artery measurement

    Ultrasound of popliteal artery with diameter measured in mm

    1 day

Secondary Outcomes (6)

  • Smoking habits

    1 day

  • Other cardiovascular risk factors

    1 day

  • History of cardiovascular diseases

    1 day

  • Family history for aneurysmal disease

    1 day

  • Time-consuming

    1 day

  • +1 more secondary outcomes

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women or Men at high risk for aneurysmal disease

You may qualify if:

  • Women aged ≥65 years who are current smokers
  • Men aged ≥65 years
  • Women or Men aged ≥55 years with family history (first-degree relatives) for Abdominal Aortic Aneurysm (AAA) or popliteal artery aneurysm (PAA)

You may not qualify if:

  • Patient with known diagnosis of AAA or PAA
  • Patient already operated for AAA or PAA
  • AAA/PAA screening or arterial assessment of lower limbs within the last 12 months
  • Inability to understand and/or sign study consent
  • Inability to access follow-up controls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Ospedale di Castelfranco Veneto, AULSS 2 Marca Trevigiana, Via dei Carpani 16/Z

Castelfranco Veneto, TV, I-31033, Italy

Location

UOC Clinica Medica 1, Azienda Ospedale - Università di Padova, Via Nicolò Giustiniani 2

Padua, I-35128, Italy

Location

UOSD Percorso Trombosi. Dipartimento di Scienze dell'Invecchiamento, Ortopediche e Reumatologiche. Fondazione Policlinico Universitario A. Gemelli IRCCS. Largo Agostino Gemelli 8

Roma, I-00168, Italy

Location

UOS Angiologia Medica, Ospedale di Rovigo ULSS 5 Polesana, Viale Tre Martiri 140

Rovigo, I-45100, Italy

Location

Centre Hospitalier Universitaire Vaudois (CHUV), Service d'Angiologie

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (6)

  • Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.

    PMID: 29268916BACKGROUND

  • Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Bjorck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. No abstract available.

    PMID: 30528142BACKGROUND

  • Svensjo S, Mani K, Bjorck M, Lundkvist J, Wanhainen A. Screening for abdominal aortic aneurysm in 65-year-old men remains cost-effective with contemporary epidemiology and management. Eur J Vasc Endovasc Surg. 2014 Apr;47(4):357-65. doi: 10.1016/j.ejvs.2013.12.023. Epub 2014 Jan 31.

    PMID: 24485841BACKGROUND

  • Farber A, Angle N, Avgerinos E, Dubois L, Eslami M, Geraghty P, Haurani M, Jim J, Ketteler E, Pulli R, Siracuse JJ, Murad MH. The Society for Vascular Surgery clinical practice guidelines on popliteal artery aneurysms. J Vasc Surg. 2022 Jan;75(1S):109S-120S. doi: 10.1016/j.jvs.2021.04.040. Epub 2021 May 20.

    PMID: 34023430BACKGROUND

  • Aboyans V, Bataille V, Bliscaux P, Ederhy S, Filliol D, Honton B, Kurtz B, Messas E, Mohty D, Brochet E, Kownator S; investigators of the E2T3A study. Effectiveness of screening for abdominal aortic aneurysm during echocardiography. Am J Cardiol. 2014 Oct 1;114(7):1100-4. doi: 10.1016/j.amjcard.2014.07.024. Epub 2014 Jul 18.

    PMID: 25127549BACKGROUND

  • Matsumura Y, Ochi Y, Wada M, Hirakawa D, Yamanaka S, Kamioka M, Kitaoka H, Orihashi K, Nakaoka Y, Doi Y, Sugiura T. Usefulness of Screening for Abdominal Aortic Aneurysm During Transthoracic Echocardiography in Women >/=50 Years of Age. Am J Cardiol. 2018 Dec 15;122(12):2147-2150. doi: 10.1016/j.amjcard.2018.08.050. Epub 2018 Sep 22.

    PMID: 30360889BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalPopliteal Artery Aneurysm

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Lucia Mazzolai, MD, PhD

    Centre Hospitalier Universitaire Vaudois

    STUDY CHAIR

  • Adriano Alatri, MD

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Senior Physician

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 4, 2022

Study Start

June 1, 2020

Primary Completion

February 23, 2026

Study Completion (Estimated)

June 30, 2029

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

CH(1)IT(4)