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

12. Februar 2018 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

240

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Intervention group: Angioplasty
Angioplasty with or without stent of the iliac artery
Verfahren: 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.
Andere Namen:
  • Endovaskuläre Behandlung
Aktiver Komparator: Control: Supervised Exercise Therapy
Supervised exercise therapy by a physiotherapist
Sonstiges: 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.
Andere Namen:
  • Konservative Behandlung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Disease specific Quality of Life
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Painfree Walking Distance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: During 12 months
Complications related to both interventions during 12 months.
During 12 months
Treatment failures
Zeitfenster: During 12 months
A treatment failure is defined as crossover to the other treatment arm.
During 12 months
Costs
Zeitfenster: During 12 months
Costs during 1 year.
During 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

M.J.W. Koelemaij

Mitarbeiter

ZonMw: The Netherlands Organisation for Health Research and Development

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. November 2010

Primärer Abschluss (Tatsächlich)

1. Mai 2016

Studienabschluss (Tatsächlich)

1. Mai 2016

Studienanmeldedaten

Zuerst eingereicht

28. Juni 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juni 2011

Zuerst gepostet (Schätzen)

30. Juni 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Februar 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Februar 2018

Zuletzt verifiziert

1. Februar 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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