Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm (DAAP-PR)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Aneurysm, Abdominal; Popliteal Artery Aneurysm

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 In contrast, data regarding the risk and characteristics of AAA in women are very limited and outdated.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.

• Study Type: Observational
• Enrollment (Actual): 507

Contacts and Locations

Study Locations

• Italy
  • Padua, Italy, I-35128
    • UOC Clinica Medica 1, Azienda Ospedale - Università di Padova, Via Nicolò Giustiniani 2
  • Roma, Italy, I-00168
    • UOSD Percorso Trombosi. Dipartimento di Scienze dell'Invecchiamento, Ortopediche e Reumatologiche. Fondazione Policlinico Universitario A. Gemelli IRCCS. Largo Agostino Gemelli 8
  • Rovigo, Italy, I-45100
    • UOS Angiologia Medica, Ospedale di Rovigo ULSS 5 Polesana, Viale Tre Martiri 140
  • TV
    • Castelfranco Veneto, TV, Italy, I-31033
      • Ospedale di Castelfranco Veneto, AULSS 2 Marca Trevigiana, Via dei Carpani 16/Z
• Switzerland
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois (CHUV), Service d'Angiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women or Men at high risk for aneurysmal disease

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking habits	Defined by active smoking, former smoking, never smoking	1 day
Other cardiovascular risk factors	Arterial hypertension, Diabetes, Dyslipidemia, Obesity	1 day
History of cardiovascular diseases	Coronary artery disease, cerebrovascular disease, lower extremity peripheral artery disease, venous thromboembolism	1 day
Family history for aneurysmal disease	First-degree relatives with aneurysmal disease	1 day
Time-consuming	Time needed to perform screening	1 day
Surgical intervention for aneurysm	Number of aneurysm operated during follow-up	36 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Study Chair: Lucia Mazzolai, MD, PhD, Centre Hospitalier Universitaire Vaudois; Principal Investigator: Adriano Alatri, MD, Centre Hospitalier Universitaire Vaudois

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): February 23, 2026
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Screening; Abdominal aortic aneurysm; Popliteal aneurysm
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Popliteal Artery Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: DAAP-PR study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No