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Popliteal Artery AneurysmNCT04188808

Prospective Case-control Study in Patients With PAA

A study testing Bypass surgery in people with Popliteal Artery Aneurysm and Peripheral Arterial Disease, run by Rebecka Hultgren at 2 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

The overall objective is to highlight different aspects of care in patients with PAA before and after treatment, and identifying factors that influence the outcome of PAA patients. Read more about this study

Who is it for?
Any age
What is being tested?
Bypass surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
2 sitesSweden
Study dates
1 Sep 2018to Dec 2028
Phase
Interventional

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All patients scheduled for elective surgery of PAA (asymptomatic)
  • All patients scheduled for elective surgery of PAD
  • Elective open surgery
  • Intermittent claudication
  • Resting pain or very limited minor tissue loss

Who cannot join

  • Cognitive failure
  • Major tissue loss
  • severe pain
  • if one cannot assimilate information in Swedish and understand the questionnaires

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rebecka Hultgren, Prof contact

+46851776596

rebecka.hultgren@ki.se

Iva Jergovic, MD contact

+46851770947

iva.jergovic@sll.se

Sweden2 sites, 2 recruiting
  • Sahlgrenska University Hospital

    Gothenburg

    Joakim Nordanstig, MD, assoc prof.

    Recruiting
  • Karolinska University Hospital

    Stockholm

    Iva Jergovic, MD

    Recruiting

Other trials in Sweden

About this study

Official title: A Prospective Case-control Study of the Quality of Life in Patients With Aneurysmatic or Occlusive Disease in the Lower Limb

The overall objective is to highlight different aspects of care in patients with PAA before and after treatment, and identifying factors that influence the outcome of PAA patients.

Read the detailed description

An aneurysm is most commonly defined as a permanent focal dilatation of an artery to 1.5 times its normal diameter. While the abdominal aorta is the most common site of aneurysm formation, the popliteal artery (PA) represents the second most common site of aneurysm formation, accounting for more than 70 percent of all peripheral aneurysms. A popliteal artery aneurysm (PAA) is a focal dilatation of the popliteal artery (red arrow). PAAs are rare in the general population but more commonly found in patient populations with other aneurysms, such as abdominal aortic aneurysm (AAA). Within the general population, PAAs are predominantly found in men and are extremely rare in women. There are few studies on the prevalence of PAAs in healthy individuals, but 14-19% of male and 12% of female AAA patients have PAAs. There is no clear correlation between the diameter of the AAA and the prevalence of PAA. There is furthermore a lack of consensus of the precise arterial diameter that defines a PAA.

It is paramount to identify and treat PAA patients before acute symptoms develop, given the high risk of major complications associated with acute presentation, such as major amputation. Unfortunately, there is a lack of knowledge of the natural history for PAAs, which is why surgical procedures are recommended mainly based on clinical experience and guidelines developed from insufficient scientific information. The preventive purpose, more specifically to prevent the risk of acute symptom development, should be evaluated against the frequency of complications inflicted by surgical treatment, so called "surgical risk". For this reason, it is important to evaluate the patients' health-related quality of life (HRQoL) before and after treatment in order to determine how the surgical treatment affect patients. In general, the Health-Related Quality of Life (HRQoL) is therefore emerging as an important outcome measure for interventions designed to improve patient's health, well-being, or both. There is very limited prior knowledge of HRQoL outcomes following surgical treatment of PAAs and the PAA patient's HRQoL, and whether-and to what extent- it becomes affected by the surgical treatment, is yet unknown. The surgical treatment in PAA patients and patients with peripheral arterial disease (PAD), are comparable whereas the underlying pathologies are distinct. Thus, peripheral arterial disease patients commonly experience substantial symptom relief following a surgical intervention (i.e. lower limb pain is alleviated, or ischemic wound healing is promoted). By contrast, PAA patients are often asymptomatic prior to surgery. It is therefore conceivable that a surgical intervention in PAA patients translates to a lower HRQoL after surgery than what is observed following bypass surgery for PAD. However, this needs to be further explored and confirmed in prospective studies.

Aim To investigate whether the QoL of PAA patients compared to PAD patients after surgical and potential changes over time.

Hypothesis Compared to PAD patients, femoropopliteal/femorodistal bypass surgery interventions undertaken on PAA patients result in a more pronounced negative HRQoL impact.

Being tested
Bypass surgery
Keywords
Open vascular surgery, Vascular disease
Medical subject headings
Popliteal Artery Aneurysm, Peripheral Arterial Disease, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bypass surgeryOther

    All patients scheduled for elective surgery of PAA and PAD.

Study groups in NCT04188808
Study groupRoleWhat they receive
Popliteal artery aneurysmExperimentalAsymptomatic popliteal artery aneurysm patients will undergo surgery with a femoropopliteal/femorodistal bypass
Receives: Other: Bypass surgery
Peripheral artery diseaseActive comparatorPatients with peripheral artery disease defined as (ankle - brachial index, ABI <0.5 or typical symptoms); intermittent claudication (IC), or resting pain and/or minor tissue loss. Will undergo surgery with a femoropopliteal/femorodistal bypass
Receives: Other: Bypass surgery

What is being measured

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

  1. SF-36

    A 36-item questionnaire that measures 8 dimensions of physical and mental health. ( 0-100) Positive if high

    Measured: Five years

Secondary outcomes (1)
  1. EQ-5D

    EQ-5D is a standardized instrument for measuring generic health status (0-100) 100 best Health and 0 worst helath

    Measured: Five years

Timeline

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

  1. First posted6 Dec 2019
  2. Study start1 Sep 2018
  3. Primary completionJan 2024 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04188808
Sponsor's protocol ID
NPAA0831365
Status last verified
Nov 2022
First submitted
13 Nov 2019
Last updated
1 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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