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Aortic Aneurysm, AbdominalDAAP-PRNCT05360108

Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm

An observational study of Aortic Aneurysm, Abdominal and Popliteal Artery Aneurysm, run by Centre Hospitalier Universitaire Vaudois at 5 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 55 to 85 years
How many people
507 participants
Where
5 sitesin 2 countries
Study dates
1 Jun 2020to 30 Jun 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Women or Men at high risk for aneurysmal disease

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Italy4 sites

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

    Castelfranco Veneto, TV, I-31033

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

    Padova, I-35128

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

    Roma, I-00168

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

    Rovigo, I-45100

Other trials in Italy

Switzerland1 site

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

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm in At-risk Population (DAAP-PR Study)

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.

Read the detailed description

Abdominal aortic aneurysm (AAA) remains a highly topical issue given the potentially dramatic consequences associated with its rupture. In men, the prevalence of AAA is declining, probably due to improved management of risk factors. However, the most recent studies and international recommendations have reaffirmed that screening for AAA in men is still important and cost-effective. In contrast, data regarding the risk and characteristics of AAA in women are very limited and outdated. For this reason, the recommendations are contrasting and not univocal. About 35% of patients with AAA have a second aneurysm more distally. Popliteal artery aneurysm (PAA) is the most common. Like AAA, PAA is often asymptomatic and its main complication is thrombotic occlusion resulting in acute/chronic ischemia of the affected limb and a high prevalence of permanent sequelae (mainly amputation). Data on epidemiology and risk factors of PAA are very limited in men and absent in women. In addition, the benefit of PAA screening has never been assessed so far.

The aim of this study is to evaluate, by an opportunistic screening program based on vascular ultrasound, the prevalence and characteristics of AAA and PAA in a female population as well as the prevalence and characteristics of PAA in male population. The project represents the first screening program for popliteal aneurysm. Finally, the results will allow us to better assess need for and modalities of a screening program.

Keywords
Abdominal aortic aneurysm, Popliteal aneurysm, Screening
Medical subject headings
Aortic Aneurysm, Abdominal, Popliteal Artery Aneurysm

What is being measured

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

  1. Abdominal aortic measurement

    Ultrasound of infrarenal aorta with diameter measured in mm

    Measured: 1 day

  2. Popliteal artery measurement

    Ultrasound of popliteal artery with diameter measured in mm

    Measured: 1 day

Secondary outcomes (6)

  1. Smoking habits

    Defined by active smoking, former smoking, never smoking

    Measured: 1 day

  2. Other cardiovascular risk factors

    Arterial hypertension, Diabetes, Dyslipidemia, Obesity

    Measured: 1 day

  3. History of cardiovascular diseases

    Coronary artery disease, cerebrovascular disease, lower extremity peripheral artery disease, venous thromboembolism

    Measured: 1 day

  4. Family history for aneurysmal disease

    First-degree relatives with aneurysmal disease

    Measured: 1 day

  5. Time-consuming

    Time needed to perform screening

    Measured: 1 day

  6. Surgical intervention for aneurysm

    Number of aneurysm operated during follow-up

    Measured: 36 months

Timeline

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

  1. First posted4 May 2022
  2. Study start1 Jun 2020
  3. Primary completion23 Feb 2026
  4. Study completion30 Jun 2029 (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
507 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05360108
Sponsor's protocol ID
DAAP-PR study
Acronym
DAAP-PR
Status last verified
Mar 2026
First submitted
26 Apr 2022
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29268916

  • 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.

    PubMed 30528142

  • 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.

    PubMed 24485841

  • 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.

    PubMed 34023430

  • 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.

    PubMed 25127549

  • 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.

    PubMed 30360889

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Aneurysm, Abdominal and Popliteal Artery Aneurysm, run by Centre Hospitalier Universitaire Vaudois at 5 sites in 2 countries.

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 5 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: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy, Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

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?

Abdominal aortic measurement (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT05360108, which also lists 6 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 16 Mar 2026.

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