SUPER Study; SUPERvised Exercise or Angioplasty for Intermittent Claudication Due to an Iliac Artery Obstruction. (SUPER)
Recruitment status was: Recruiting
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.
|Intermittent Claudication Peripheral Arterial Disease||Procedure: Percutaneous Transluminal Angioplasty Other: Supervised Exercise Therapy|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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.
- 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.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Intervention group: Angioplasty||
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 Name: Endovascular treatment
|No Intervention: Control: Supervised Exercise Therapy||
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.
Other Name: Conservative treatment
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.
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.
Multicenter randomized controlled trial.
400 patients with IC due to an iliac artery stenosis or occlusion.
SET and PTA.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385774
|Contact: Franceline A Frans, M.D.||+firstname.lastname@example.org|
|Contact: Mark JW Koelemay, M.D., Ph.D.||+email@example.com|
|Flevoziekenhuis||Not yet recruiting|
|Almere, Netherlands, 1315 RA|
|Contact: M Willems|
|Sub-Investigator: M Willems|
|Sint Lucas Andreas Ziekenhuis||Not yet recruiting|
|Amsterdam, Netherlands, 1061 AE|
|Contact: R C van Nieuwenhuizen|
|Sub-Investigator: R C van Nieuwenhuizen|
|VU Medical Center||Not yet recruiting|
|Amsterdam, Netherlands, 1081 HV|
|Contact: A WJ Hoksbergen|
|Sub-Investigator: A WJ Hoksbergen|
|Onze Lieve Vrouwe Gasthuis||Recruiting|
|Amsterdam, Netherlands, 1091 AC|
|Contact: A C Vahl|
|Sub-Investigator: A C Vahl|
|Academic Medical Center||Recruiting|
|Amsterdam, Netherlands, 1105 AZ|
|Contact: Franceline A Frans, M.D. +31-205662936 firstname.lastname@example.org|
|Contact: Mark JW Koelemay, M.D., Ph.D. +31-205669111 email@example.com|
|Principal Investigator: Mark JW Koelemay, M.D., Ph.D.|
|Principal Investigator: Jim A Reekers, M.D., Ph.D.|
|Principal Investigator: Dink A Legemate, M.D., Ph.D.|
|Sub-Investigator: Shandra Bipat, Ph.D.|
|Sub-Investigator: R HH Engelbert, Ph.D.|
|Sub-Investigator: R J de Haan, Ph.D.|
|Sub-Investigator: M GW Dijkgraaf, Ph.D.|
|Gelre ziekenhuizen||Not yet recruiting|
|Apeldoorn, Netherlands, 7334 DZ|
|Contact: H C Buscher|
|Sub-Investigator: H C Buscher|
|Ziekenhuis Rijnstate||Not yet recruiting|
|Arnhem, Netherlands, 6815 AD|
|Contact: M Reijnen|
|Sub-Investigator: M Reijnen|
|Rode Kruis Ziekenhuis||Recruiting|
|Beverwijk, Netherlands, 1942 LE|
|Contact: A J de Nie, M.D.|
|Sub-Investigator: A J de Nie|
|Deventer Ziekenhuis||Not yet recruiting|
|Deventer, Netherlands, 7416 SE|
|Contact: B HP Elsman|
|Sub-Investigator: B HP Elsman|
|Kennemer Gasthuis||Not yet recruiting|
|Haarlem, Netherlands, 2035 RC|
|Contact: E GJ Vermeulen|
|Sub-Investigator: E GJ Vermeulen|
|Tergooiziekenhuizen||Not yet recruiting|
|Hilversum, Netherlands, 1213 XZ|
|Contact: E JF Hollander|
|Sub-Investigator: E JF Hollander|
|Spaarne Ziekenhuis||Not yet recruiting|
|Hoofddorp, Netherlands, 2134 TM|
|Contact: D Nio|
|Sub-Investigator: D Nio|
|St Antonius Ziekenhuis||Recruiting|
|Nieuwegein, Netherlands, 3435 CM|
|Contact: J P de Vries|
|Sub-Investigator: J P de Vries|
|UMC St. Radboud||Not yet recruiting|
|Nijmegen, Netherlands, 6525 GA|
|Contact: J van der Vliet|
|Sub-Investigator: J van der Vliet|
|Waterland ziekenhuis||Not yet recruiting|
|Purmerend, Netherlands, 1441 RN|
|Contact: Th AA van den Broek|
|Sub-Investigator: Th AA van den Broek|
|Principal Investigator:||Mark JW Koelemay, M.D., Ph.D||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Principal Investigator:||Jim A Reekers, M.D., Ph.D.||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Principal Investigator:||Dink A Legemate, M.D.,Ph.D.||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Study Director:||Shandra Bipat, Ph.D.||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|