NCT01385774

SUPER Study; SUPERvised Exercise or Angioplasty for Intermittent Claudication Due to an Iliac Artery Obstruction.

SUPERvised Exercise Therapy (SET) or Immediate Percutaneous Transluminal Angioplasty (PTA) for Intermittent Claudication (IC) in Patients With an Iliac Artery Obstruction: A Randomized Controlled Trial. SUPER Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: M.J.W. Koelemaij · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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 distance on a standardized treadmill test with a speed of 3.2 km/h at 10% incline after 1 year. Secondary outcomes are pain-free walking distance, generic Qol, functional status, complications, number of treatment failures and costs. Economic evaluation comprises a cost-effectiveness and cost-utility analysis from a societal perspective, with the costs per patient able to walk maximal, respectively the costs per Quality Adjusted Life-Year (QALY) as outcome measures.

Conditions

• Intermittent Claudication
• Peripheral Arterial Disease

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Transluminal Angioplasty	The Percutaneous Transluminal Angioplasty (PTA) procedure will be performed by an experienced interventional radiologist using a conventional guide wire and balloon catheter technique. A stent will be placed in cases in which the residual mean pressure gradient is greater than 10 mmHg across the treated site or when more than 30% stenosis after the procedure is detected. All PTA patients are encouraged perform at least three walking sessions every day.
OTHER	Supervised Exercise Therapy	Supervised Exercise Therapy (SET) will take place in the hospital or community based according to the guidelines of the Dutch Society for Physiotherapists. The duration of the treatment will be at least 6 months and with a frequency of 2 times a week for at least 60 minutes and an intensity near maximum pain barrier (defined as pain of which it is not possible to be distracted). The frequency of the training will decrease after 3 months and the patients will receive homework, make a plan and keep a log of their exercise activities. Furthermore the program consists of walking pattern improvement and enhancement of endurance and strength. All SET patients are encouraged to perform at least three walking sessions every day on their own.

Timeline

• Start date: 2010-11-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2011-06-30
• Last updated: 2018-02-13

Locations

15 sites across 1 country: Netherlands