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

12 februari 2018 uppdaterad av: M.J.W. Koelemaij

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

240

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Nederländerna
      • Almere, Nederländerna, 1315 RA
        • Flevoziekenhuis
      • Amsterdam, Nederländerna, 1105 AZ
        • Academic Medical Center
      • Amsterdam, Nederländerna, 1091 AC
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Nederländerna, 1081 HV
        • VU Medical Center
      • Amsterdam, Nederländerna, 1061 AE
        • Sint Lucas Andreas Ziekenhuis
      • Apeldoorn, Nederländerna, 7334 DZ
        • Gelre Ziekenhuizen
      • Arnhem, Nederländerna, 6815 AD
        • Ziekenhuis Rijnstate
      • Beverwijk, Nederländerna, 1942 LE
        • Rode Kruis Ziekenhuis
      • Deventer, Nederländerna, 7416 SE
        • Deventer Ziekenhuis
      • Haarlem, Nederländerna, 2035 RC
        • Kennemer Gasthuis
      • Hilversum, Nederländerna, 1213 XZ
        • Tergooiziekenhuizen
      • Hoofddorp, Nederländerna, 2134 TM
        • Spaarne Ziekenhuis
      • Nieuwegein, Nederländerna, 3435 CM
        • St Antonius Ziekenhuis
      • Nijmegen, Nederländerna, 6525 GA
        • UMC St. Radboud
      • Purmerend, Nederländerna, 1441 RN
        • Waterland Ziekenhuis

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Intervention group: Angioplasty
Angioplasty with or without stent of the iliac artery
Procedur: 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.
Andra namn:
  • Endovaskulär behandling
Aktiv komparator: Control: Supervised Exercise Therapy
Supervised exercise therapy by a physiotherapist
Övrig: 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.
Andra namn:
  • Konservativ behandling

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Disease specific Quality of Life
Tidsram: 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.
12 months
Maximum Walking Distance
Tidsram: 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.
12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Painfree Walking Distance
Tidsram: 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.
12 months
Functional Status
Tidsram: 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.
12 months
Generic Quality of Life
Tidsram: 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.
12 months
Complications
Tidsram: During 12 months
Complications related to both interventions during 12 months.
During 12 months
Treatment failures
Tidsram: During 12 months
A treatment failure is defined as crossover to the other treatment arm.
During 12 months
Costs
Tidsram: During 12 months
Costs during 1 year.
During 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

M.J.W. Koelemaij

Samarbetspartners

ZonMw: The Netherlands Organisation for Health Research and Development

Utredare

  • Huvudutredare: Mark JW Koelemay, M.D., Ph.D, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Huvudutredare: Jim A Reekers, M.D., Ph.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Huvudutredare: Dink A Legemate, M.D.,Ph.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Studierektor: Shandra Bipat, Ph.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 november 2010

Primärt slutförande (Faktisk)

1 maj 2016

Avslutad studie (Faktisk)

1 maj 2016

Studieregistreringsdatum

Först inskickad

28 juni 2011

Först inskickad som uppfyllde QC-kriterierna

29 juni 2011

Första postat (Uppskatta)

30 juni 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 februari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 februari 2018

Senast verifierad

1 februari 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 171102025;ZonMw
  • 09/285;METC AMC (Annan identifierare: Protocol number; IRB AMC Amsterdam)

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