Clinical trial NCT01385774: SUPER Study; SUPERvised Exercise or Angioplasty for Intermittent Claudication Due to an Iliac Artery Obstruction.
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intermittent Claudication
Peripheral Arterial Disease
Keywords: Intermittent Claudication
Percutaneous Transluminal Angioplasty
Supervised Exercise Therapy
Peripheral Arterial Disease
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2011-06-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older;
2. Disabling claudication as defined by surgeon based on patient's history;
3. Ankle/Brachial Index (ABI) \< 0.9 or drop in ABI \> 0.15 after exercise test;
4. Hemodynamic stenosis of the common or external iliac artery on Color Duplex Scanning (CDS) (PSV ratio ≥ 2.5 or EDV ≥ 0.6 m/s) or on Magnetic Resonance Angiography (MRA) or Computed Tomography Angiography (CTA)(\> 50% stenosis) or occlusion of the common or external iliac artery on CDS (PSV 0 m/s) or on MRA or CTA;
5. Iliac artery lesion and a concomitant stenosis in the superficial femoral artery defined as stenosis \> 50% by CDS (PSV ratio ≥ 2.5 or EDV ≥ 0.6 m/s) or on MRA or CTA, or occlusion on CDS (PSV 0 m/s) or MRA or CTA;
6. Lesion classified A, B or C according to the TASC (TransAtlantic Inter-Society Consensus) classification of aortoiliac lesions;
7. Patient is able to walk at least 2 minutes on a treadmill at 3.2 km/h and 10% incline;
8. The Maximum Walking Distance on a treadmill \< 300 meters.

Exclusion Criteria:

1. Life expectancy \< 3 months;
2. Patient is unable to complete self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc);
3. Patient is unable to give informed consent;
4. A documented contrast allergy;
5. Pregnancy;
6. Contra-indication for anticoagulant therapy;
7. Duration of current complaints \< 3 months;
8. Occlusion of the common femoral artery at the affected side;
9. Patient participates in another study;
10. Heart failure or Angina Pectoris NYHA III or IV. (NYHA III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea; NYHA IV: Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased);
11. Patient previously received Supervised Exercise Therapy (SET) according to KNGF (Dutch Society for Physiotherapists) guidelines;
12. Renal insufficiency (serum creatinin \> 150 micromol/l).

Primary outcomes:
measure: Disease specific Quality of Life
timeFrame: 12 months
measure: Maximum Walking Distance
timeFrame: 12 months
Secondary outcomes:
measure: Painfree Walking Distance
timeFrame: 12 months
measure: Functional Status
timeFrame: 12 months
measure: Generic Quality of Life
timeFrame: 12 months
measure: Complications
timeFrame: During 12 months
measure: Treatment failures
timeFrame: During 12 months
measure: Costs
timeFrame: During 12 months
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: Sint Lucas Andreas Ziekenhuis
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Apeldoorn
country: Netherlands
facility: Gelre ziekenhuizen
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
city: Purmerend
country: Netherlands
facility: Waterland ziekenhuis
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Mark JW Koelemay, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jim A Reekers, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Dink A Legemate, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Shandra Bipat, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Frans FA, Zagers MB, Jens S, Bipat S, Reekers JA, Koelemay MJ. The relationship of walking distances estimated by the patient, on the corridor and on a treadmill, and the Walking Impairment Questionnaire in intermittent claudication. J Vasc Surg. 2013 Mar;57(3):720-727.e1. doi: 10.1016/j.jvs.2012.09.044. Epub 2013 Jan 11.
citation: Frans FA, Bipat S, Reekers JA, Legemate DA, Koelemay MJ; SUPER Study Collaborators. SUPERvised exercise therapy or immediate PTA for intermittent claudication in patients with an iliac artery obstruction--a multicentre randomised controlled trial; SUPER study design and rationale. Eur J Vasc Endovasc Surg. 2012 Apr;43(4):466-71. doi: 10.1016/j.ejvs.2012.01.014. Epub 2012 Feb 10.