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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01385774
First received: June 28, 2011
Last updated: July 7, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Intermittent Claudication
Peripheral Arterial Disease
Procedure: Percutaneous Transluminal Angioplasty
Other: Supervised Exercise Therapy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Disease specific Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Painfree Walking Distance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    Complications related to both interventions during 12 months.

  • Treatment failures [ Time Frame: During 12 months ] [ Designated as safety issue: No ]
    A treatment failure is defined as crossover to the other treatment arm.

  • Costs [ Time Frame: During 12 months ] [ Designated as safety issue: No ]
    Costs during 1 year.


Estimated Enrollment: 400
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)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385774

Contacts
Contact: Franceline A Frans, M.D. +31-205662936 info@superstudie.nl
Contact: Mark JW Koelemay, M.D., Ph.D. +31-205666654 m.j.koelemaij@amc.uva.nl

Locations
Netherlands
Flevoziekenhuis Not yet recruiting
Almere, Netherlands, 1315 RA
Contact: M Willems         
Sub-Investigator: M Willems         
Academic Medical Center Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Franceline A Frans, M.D.    +31-205662936    info@superstudie.nl   
Contact: Mark JW Koelemay, M.D., Ph.D.    +31-205669111    m.j.koelemaij@amc.uva.nl   
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.         
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         
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         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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)
  More Information

Additional Information:
No publications provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. M.J.W. Koelemay, Academic Medical Center
ClinicalTrials.gov Identifier: NCT01385774     History of Changes
Other Study ID Numbers: 171102025;ZonMw, 09/285;METC AMC
Study First Received: June 28, 2011
Last Updated: July 7, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: ZonMw, Netherlands Organisation for Health Research and Development
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Intermittent Claudication
Percutaneous Transluminal Angioplasty
Supervised Exercise Therapy
Peripheral Arterial Disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014