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

12 février 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

240

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Intervention group: Angioplasty
Angioplasty with or without stent of the iliac artery
Procédure: 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.
Autres noms:
  • Traitement endovasculaire
Comparateur actif: Control: Supervised Exercise Therapy
Supervised exercise therapy by a physiotherapist
Autre: 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.
Autres noms:
  • Traitement conservateur

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Disease specific Quality of Life
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Painfree Walking Distance
Délai: 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
Délai: 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
Délai: 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
Délai: During 12 months
Complications related to both interventions during 12 months.
During 12 months
Treatment failures
Délai: During 12 months
A treatment failure is defined as crossover to the other treatment arm.
During 12 months
Costs
Délai: During 12 months
Costs during 1 year.
During 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

M.J.W. Koelemaij

Collaborateurs

ZonMw: The Netherlands Organisation for Health Research and Development

Les enquêteurs

  • Chercheur principal: Mark JW Koelemay, M.D., Ph.D, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Chercheur principal: Jim A Reekers, M.D., Ph.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Chercheur principal: Dink A Legemate, M.D.,Ph.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Directeur d'études: Shandra Bipat, Ph.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 novembre 2010

Achèvement primaire (Réel)

1 mai 2016

Achèvement de l'étude (Réel)

1 mai 2016

Dates d'inscription aux études

Première soumission

28 juin 2011

Première soumission répondant aux critères de contrôle qualité

29 juin 2011

Première publication (Estimation)

30 juin 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 février 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 février 2018

Dernière vérification

1 février 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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