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

Primary Purpose

Intermittent Claudication, Peripheral Arterial Disease

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Percutaneous Transluminal Angioplasty
Supervised Exercise Therapy
Sponsored by
M.J.W. Koelemaij
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring Intermittent Claudication, Percutaneous Transluminal Angioplasty, Supervised Exercise Therapy, Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Flevoziekenhuis
  • Sint Lucas Andreas Ziekenhuis
  • VU Medical Center
  • Onze Lieve Vrouwe Gasthuis
  • Academic Medical Center
  • Gelre ziekenhuizen
  • Ziekenhuis Rijnstate
  • Rode Kruis Ziekenhuis
  • Deventer Ziekenhuis
  • Kennemer Gasthuis
  • Tergooiziekenhuizen
  • Spaarne Ziekenhuis
  • St Antonius Ziekenhuis
  • UMC St. Radboud
  • Waterland ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention group: Angioplasty

Control: Supervised Exercise Therapy

Arm Description

Angioplasty with or without stent of the iliac artery

Supervised exercise therapy by a physiotherapist

Outcomes

Primary Outcome Measures

Disease specific Quality of Life
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
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
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
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
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
Complications related to both interventions during 12 months.
Treatment failures
A treatment failure is defined as crossover to the other treatment arm.
Costs
Costs during 1 year.

Full Information

First Posted
June 28, 2011
Last Updated
February 12, 2018
Sponsor
M.J.W. Koelemaij
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01385774
Brief Title
SUPER Study; SUPERvised Exercise or Angioplasty for Intermittent Claudication Due to an Iliac Artery Obstruction.
Acronym
SUPER
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Study terminated after 240 patients because of slow accrual and lack of additional funding
Study Start Date
November 2010 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
M.J.W. Koelemaij
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication, Peripheral Arterial Disease
Keywords
Intermittent Claudication, Percutaneous Transluminal Angioplasty, Supervised Exercise Therapy, Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group: Angioplasty
Arm Type
Active Comparator
Arm Description
Angioplasty with or without stent of the iliac artery
Arm Title
Control: Supervised Exercise Therapy
Arm Type
Active Comparator
Arm Description
Supervised exercise therapy by a physiotherapist
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Transluminal Angioplasty
Other Intervention Name(s)
Endovascular treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Supervised Exercise Therapy
Other Intervention Name(s)
Conservative treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease specific Quality of Life
Description
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.
Time Frame
12 months
Title
Maximum Walking Distance
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Painfree Walking Distance
Description
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.
Time Frame
12 months
Title
Functional Status
Description
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.
Time Frame
12 months
Title
Generic Quality of Life
Description
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.
Time Frame
12 months
Title
Complications
Description
Complications related to both interventions during 12 months.
Time Frame
During 12 months
Title
Treatment failures
Description
A treatment failure is defined as crossover to the other treatment arm.
Time Frame
During 12 months
Title
Costs
Description
Costs during 1 year.
Time Frame
During 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older; Disabling claudication as defined by surgeon based on patient's history; Ankle/Brachial Index (ABI) < 0.9 or drop in ABI > 0.15 after exercise test; 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; 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; Lesion classified A, B or C according to the TASC (TransAtlantic Inter-Society Consensus) classification of aortoiliac lesions; Patient is able to walk at least 2 minutes on a treadmill at 3.2 km/h and 10% incline; The Maximum Walking Distance on a treadmill < 300 meters. Exclusion Criteria: Life expectancy < 3 months; Patient is unable to complete self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc); Patient is unable to give informed consent; A documented contrast allergy; Pregnancy; Contra-indication for anticoagulant therapy; Duration of current complaints < 3 months; Occlusion of the common femoral artery at the affected side; Patient participates in another study; 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); Patient previously received Supervised Exercise Therapy (SET) according to KNGF (Dutch Society for Physiotherapists) guidelines; Renal insufficiency (serum creatinin > 150 micromol/l).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark JW Koelemay, M.D., Ph.D
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jim A Reekers, M.D., Ph.D.
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dink A Legemate, M.D.,Ph.D.
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shandra Bipat, Ph.D.
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Study Director
Facility Information:
Facility Name
Flevoziekenhuis
City
Almere
ZIP/Postal Code
1315 RA
Country
Netherlands
Facility Name
Sint Lucas Andreas Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
Facility Name
VU Medical Center
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Gelre ziekenhuizen
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Facility Name
Ziekenhuis Rijnstate
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Rode Kruis Ziekenhuis
City
Beverwijk
ZIP/Postal Code
1942 LE
Country
Netherlands
Facility Name
Deventer Ziekenhuis
City
Deventer
ZIP/Postal Code
7416 SE
Country
Netherlands
Facility Name
Kennemer Gasthuis
City
Haarlem
ZIP/Postal Code
2035 RC
Country
Netherlands
Facility Name
Tergooiziekenhuizen
City
Hilversum
ZIP/Postal Code
1213 XZ
Country
Netherlands
Facility Name
Spaarne Ziekenhuis
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
St Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
UMC St. Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Waterland ziekenhuis
City
Purmerend
ZIP/Postal Code
1441 RN
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23313183
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.
Results Reference
derived
PubMed Identifier
22326696
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.
Results Reference
derived
Links:
URL
http://www.superstudie.nl/
Description
SUPER study website

Learn more about this trial

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

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