NCT04188808

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Sep 2018Dec 2028

Study Start

First participant enrolled

September 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

5.3 years

First QC Date

November 13, 2019

Last Update Submit

November 30, 2022

Conditions

Popliteal Artery AneurysmPeripheral Arterial DiseaseQuality of Life

Keywords

Open vascular surgeryVascular disease

Outcome Measures

Primary Outcomes (1)

  • SF-36

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

    Five years

Secondary Outcomes (1)

  • EQ-5D

    Five years

Other Outcomes (1)

  • PHQ-9 PHQ-9

    Five years

Study Arms (2)

Popliteal artery aneurysm

EXPERIMENTAL

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

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

Other: Bypass surgery

Interventions

Bypass surgeryOTHER

All patients scheduled for elective surgery of PAA and PAD.

Peripheral artery diseasePopliteal artery aneurysm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Popliteal Artery AneurysmPeripheral Arterial DiseaseVascular Diseases

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

AneurysmCardiovascular DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Rebecka Hultgren, Prof

    Karolinska Instutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecka Hultgren, Prof

CONTACT

+46851776596rebecka.hultgren@ki.se

Iva Jergovic, MD

CONTACT

+46851770947iva.jergovic@sll.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2019

First Posted

December 6, 2019

Study Start

September 1, 2018

Primary Completion

January 1, 2024

Study Completion (Estimated)

December 1, 2028

Last Updated

December 1, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)