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.
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
- Conditions the study is for
- Popliteal Artery Aneurysm, Peripheral Arterial Disease, Quality of Life
- 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
- 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 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.
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Joakim Nordanstig, MD, assoc prof.
- Recruiting
Karolinska University Hospital
Stockholm
Iva Jergovic, MD
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 group | Role | What they receive |
|---|---|---|
| Popliteal artery aneurysm | Experimental | Asymptomatic popliteal artery aneurysm patients will undergo surgery with a femoropopliteal/femorodistal bypass Receives: Other: Bypass surgery |
| Peripheral artery disease | Active comparator | Patients 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.
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)
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.
- First posted6 Dec 2019
- Study start1 Sep 2018
- Primary completionJan 2024 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Popliteal Artery AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rebecka Hultgren
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Karolinska Institutet, Stockholm South General Hospital, Sahlgrenska University Hospital
- Responsible party
- Sponsor-investigator, Rebecka Hultgren, Karolinska University Hospital
- Investigators
- Rebecka Hultgren, Prof, Principal investigator, Karolinska Instutet
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case-control Study of the Quality of Life in Patients With Aneurysmatic or Occlusive Disease in the Lower Limb
- ClinicalTrials.gov ID
- NCT04188808
- Acronym / sponsor ID
- NPAA0831365
- Keywords
- Open vascular surgery, Vascular disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Rebecka HultgrenUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Karolinska Institutet, Stockholm South General Hospital, Sahlgrenska University Hospital
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Popliteal artery aneurysm | Experimental | Other: Bypass surgeryAsymptomatic popliteal artery aneurysm patients will undergo surgery with a femoropopliteal/femorodistal bypass |
| Peripheral artery disease | Active comparator | Other: Bypass surgeryPatients 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Cognitive failure
- Major tissue loss
- severe pain
- if one cannot assimilate information in Swedish and understand the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bypass surgeryAll patients scheduled for elective surgery of PAA and PAD. | Other | Peripheral artery disease, Popliteal artery aneurysm |
Primary outcome
SF-36
Time frame: Five years
A 36-item questionnaire that measures 8 dimensions of physical and mental health. ( 0-100) Positive if high
1 secondary outcome
EQ-5D
Time frame: Five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecka Hultgren, Prof principal investigator
Karolinska Instutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bypass surgery in people with Popliteal Artery Aneurysm and Peripheral Arterial Disease, run by Rebecka Hultgren at 2 sites in Sweden.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Contact Rebecka Hultgren, Prof (+46851776596, rebecka.hultgren@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2022.