Clinical Trial: SUPER Study; SUPERvised Exercise or Angioplasty for Intermittent Claudication Due to an Iliac Artery Obstruction.
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: SUPERvised Exercise Therapy (SET) or Immediate Percutaneous Transluminal Angioplasty (PTA) for Intermittent Claudication (IC) in Patients With an Iliac Artery Obstruction:
Brief Summary:
The purpose of our study is to compare the clinical effectiveness and cost-effectiveness of two treatment strategies of Intermittent Claudication (IC) due to an iliac artery obstruction: to start with SUPERvised Exercise Therapy (SET) and deferred Percutaneous Transluminal Angioplasty (PTA) in case of SET failure, or immediate PTA.
It is our hypothesis that PTA as first line treatment is more effective than SET as first line treatment with regard to maximum walking distance, quality of life and costs after one year.
Detailed Summary:
Intermittent claudication (IC) is a manifestation of cardiovascular disease, reflected by a threefold increased risk in these patients of developing serious cardiovascular events. Treatment of patients with IC is aimed at secondary prevention of cardiovascular events by control of risk factors for atherosclerotic disease, and to improve walking distance and subsequently quality of life. Supervised Exercise Therapy (SET) and Percutaneous Transluminal Angioplasty (PTA) can effectively improve pain free walking distance, but the optimal choice of treatment, specifically in patients with an iliac artery stenosis or occlusion is unclear. PTA is attractive as initial therapy since PTA of the iliac arteries has an immediate effect and it is durable. There is a lack of evidence from randomized controlled trials (RCT) to define the optimal treatment strategy for patients with IC due to iliac artery lesions; first line treatment with SET and PTA in case of failure, or immediate iliac artery PTA.
Purpose:
To define the optimal treatment strategy of IC due to an iliac artery obstruction: To start with SET and deferred PTA in case of SET failure, or immediate PTA.
Design:
Multicenter randomized controlled trial.
Patients:
400 patients with IC due to an iliac artery stenosis or occlusion.
Interventions:
SET and PTA.
Outcomes:
Primary outcomes are quality of life (Qol) recorded with the disease specific VascuQol instrument and maximum walking di
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Current Primary Outcome:
- Disease specific Quality of Life [ Time Frame: 12 months ]
Disease specific Quality of life (Qol) recorded with the disease specific VascuQol instrument 1 year after intervention.
The VascuQol will be completed at baseline and 1,6,12 months follow-up.
- Maximum Walking Distance [ Time Frame: 12 months ]
Maximum walking distance on a standardized treadmill test with a speed of 3.2 km/h at 10% incline measured 1 year after intervention.
The maximum walking distance will be assessed at baseline and 1,6,12 months follow-up.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Painfree Walking Distance [ Time Frame: 12 months ]
Painfree walking distance on a standardized treadmill test with a speed of 3.2 km/h at 10% incline 1 year after intervention.
The painfree walking distance will be assessed at baseline and 1,6,12 months follow-up.
- Functional Status [ Time Frame: 12 months ]
Functional status assessed by the AMC Linear Disability Score (ALDS) 1 year after intervention.
The ALDS will be completed at baseline and 1,6,12 months follow-up.
- Generic Quality of Life [ Time Frame: 12 months ]
Generic quality of life (Qol) recorded with the Short Form 36 (SF-36) and EQ-5D (former EuroQoL).
The SF-36 will be completed at baseline and 1,6,12 months follow-up. The EQ-5D will be completed at baseline, 1 week and 1,6,12 months follow-up.
- Complications [ Time Frame: During 12 months ]Complications related to both interventions during 12 months.
- Treatment failures [ Time Frame: During 12 months ]A treatment failure is defined as crossover to the other treatment arm.
- Costs [ Time Frame: During 12 months ]Costs during 1 year.
Original Secondary Outcome:
- Painfree Walking Distance [ Time Frame: 12 months ]
Painfree walking distance on a standardized treadmill test with a speed of 3.2 km/h at 10% incline 1 year after intervention.
The painfree walking distance will be assessed at baseline and 1,6,12 months follow-up.
- Functional Status [ Time Frame: 12 months ]
Functional status assessed by the AMC Linear Disability Score (ALDS) 1 year after intervention.
The ALDS will be completed at baseline and 1,6,12 months follow-up.
- Generic Quality of Life [ Time Frame: 12 months ]
Generic quality of life recorded with the Short Form 36 (SF-36)and EQ-5D (former EuroQoL).
The SF-36 will be completed at baseline and 1,6,12 months follow-up. The EQ-5D will be completed at baseline, 1 week and 1,6,12 months follow-up.
- Complications [ Time Frame: During 12 months ]Complications related to both interventions during 12 months.
- Treatment failures [ Time Frame: During 12 months ]A treatment failure is defined as crossover to the other treatment arm.
- Costs [ Time Frame: During 12 months ]Costs during 1 year.
Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dates:
Date Received: June 28, 2011
Date Started: November 2010
Date Completion: April 2014
Last Updated: July 7, 2011
Last Verified: May 2011
