Clinical Trial: Invasive Revascularization or Not in Intermittent Claudication

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Invasive Revascularization or Not in Intermittent Claudication

Brief Summary: Peripheral arterial disease (PAD) often causes exertion pain in the legs, intermittent claudication (CI) affecting> 10% of individuals> 65 years. A recent Swedish Health Technology Assessment Report identified only limited evidence for the effectiveness of invasive treatment for IC in patients already on exercise training. The prognosis for the extremity is usually benign and treatment therefore aims at improving quality of life. Invasive treatment can also cause serious complications. Coronary artery disease is common in IC patients increasing the risk with invasive treatment. In spite of these uncertain merits and potential risks, invasive procedures for IC are increasing and 37% of all invasive procedures for PAD in Sweden are performed for IC. The aim of this study is to evaluate the additional effects of modern invasive treatment in patients with intermittent claudication receiving modern best medical treatment (BMT). The primary hypothesis in the study is that invasive treatment in addition to BMT improves health related quality of life and walking performance compared to BMT only.

Detailed Summary:
Sponsor: Sahlgrenska University Hospital, Sweden

Current Primary Outcome: Health Related Quality of Life (HRQOL) [ Time Frame: 24 months with intermistic analysis at 12 months ]

Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL


Original Primary Outcome: Health Related Quality of Life (HRQL) [ Time Frame: 24 months ]

Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL


Current Secondary Outcome:

  • Walking performance on treadmill test [ Time Frame: 24 months with interimistic analysis at 12 months ]
    Graded treadmill test with progressively increasing speed and inclination.
  • Health Related Quality of Life (HRQOL) [ Time Frame: 60 months ]
    Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL
  • Walking performance on treadmill test [ Time Frame: 60 months ]
    Graded treadmill test with progressively increasing speed and inclination.
  • six-minutes walk test [ Time Frame: 60 months ]
    Corridor-based walk test during six minutes walk


Original Secondary Outcome: Walking performance on treadmill test [ Time Frame: 24 months ]

Graded treadmill test with progressively increasing speed and inclination.


Information By: Sahlgrenska University Hospital, Sweden

Dates:
Date Received: October 12, 2010
Date Started: March 2010
Date Completion: December 2017
Last Updated: October 12, 2016
Last Verified: October 2016