Prospective Case-control Study in Patients With PAA

NCT ID: NCT04188808

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2028-12-31

Brief 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.

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.

Conditions

Popliteal Artery Aneurysm; Peripheral Arterial Disease; Quality of Life

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Popliteal artery aneurysm

Asymptomatic popliteal artery aneurysm patients will undergo surgery with a femoropopliteal/femorodistal bypass

Group Type: EXPERIMENTAL

Bypass surgery

Intervention Type: OTHER

All patients scheduled for elective surgery of PAA and PAD.

Peripheral artery disease

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

Group Type: ACTIVE_COMPARATOR

Bypass surgery

Intervention Type: OTHER

All patients scheduled for elective surgery of PAA and PAD.

Interventions

Bypass surgery

All patients scheduled for elective surgery of PAA and PAD.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Stockholm South General Hospital

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Rebecka Hultgren

OTHER

Sponsor Role: lead

Responsible Party

Rebecka Hultgren

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rebecka Hultgren, Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska Instutet

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status: RECRUITING

Karolinska University Hospital

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Rebecka Hultgren, Prof

Role: CONTACT

rebecka.hultgren@ki.se

+46851776596

Iva Jergovic, MD

Role: CONTACT

iva.jergovic@sll.se

+46851770947

Facility Contacts

Joakim Nordanstig, MD, assoc prof.

Role: primary

Iva Jergovic, MD

Role: primary

Other Identifiers

NPAA0831365

Identifier Type: -

Identifier Source: org_study_id