Intermittent ClaudicationSUPERNCT01385774

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

A study testing Percutaneous Transluminal Angioplasty and Supervised Exercise Therapy in people with Intermittent Claudication and Peripheral Arterial Disease, run by M.J.W. Koelemaij at 15 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Intermittent Claudication, Peripheral Arterial Disease
What is being tested?: Percutaneous Transluminal Angioplasty and Supervised Exercise Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 15 sitesNetherlands
Study dates: Nov 2010to May 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 12Show fewer

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).

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Netherlands15 sites

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

Other trials in Netherlands

About this study

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

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.

Read the 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.

Conditions: Intermittent Claudication, Peripheral Arterial Disease
Being tested: Percutaneous Transluminal Angioplasty, Supervised Exercise Therapy
Keywords: Intermittent Claudication, Percutaneous Transluminal Angioplasty, Supervised Exercise Therapy, Peripheral Arterial Disease
Medical subject headings: Intermittent Claudication, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Percutaneous Transluminal AngioplastyProcedure or surgery
Also called Endovascular treatment
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.
Supervised Exercise TherapyOther
Also called Conservative treatment
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.

Study groups in NCT01385774
Study group	Role	What they receive
Intervention group: Angioplasty	Active comparator	Angioplasty with or without stent of the iliac artery Receives: Procedure: Percutaneous Transluminal Angioplasty
Control: Supervised Exercise Therapy	Active comparator	Supervised exercise therapy by a physiotherapist Receives: Other: Supervised Exercise Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months
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.
Measured: 12 months

Secondary outcomes (6)

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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Complications
Complications related to both interventions during 12 months.
Measured: During 12 months
Treatment failures
A treatment failure is defined as crossover to the other treatment arm.
Measured: During 12 months
Costs
Costs during 1 year.
Measured: During 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010May 2016

First posted30 Jun 2011 (estimated)
Study startNov 2010
Primary completionMay 2016
Study completionMay 2016

Why it stopped: Study terminated after 240 patients because of slow accrual and lack of additional funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01385774
Sponsor's protocol ID: 171102025;ZonMw
Other IDs: 09/285;METC AMC
Acronym: SUPER
Status last verified: Feb 2018
First submitted: 28 Jun 2011
Last updated: 13 Feb 2018
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 23313183
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.
PubMed 22326696

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Recruiting
Passive Calf Stretching Therapy in Peripheral Artery Disease
Peripheral Artery Disease, Claudication, Intermittent

All Intermittent Claudication trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01385774
Acronym / sponsor ID: SUPER / 171102025;ZonMw
Conditions: Intermittent Claudication, Peripheral Arterial Disease
Keywords: Intermittent Claudication, Percutaneous Transluminal Angioplasty, Supervised Exercise Therapy, Peripheral Arterial Disease
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated after 240 patients because of slow accrual and lack of additional funding
Enrolment: 240 participants (actual)
Lead sponsor: M.J.W. KoelemaijUniversity, hospital or other
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Study start: Nov 2010 (actual)
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 30 Jun 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention group: Angioplasty	Active comparator	Procedure: Percutaneous Transluminal AngioplastyAngioplasty with or without stent of the iliac artery
Control: Supervised Exercise Therapy	Active comparator	Other: Supervised Exercise TherapySupervised exercise therapy by a physiotherapist

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Percutaneous Transluminal AngioplastyAlso: Endovascular treatmentThe 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.	Procedure or surgery	Intervention group: Angioplasty
Supervised Exercise TherapyAlso: Conservative treatmentSupervised 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	Control: Supervised Exercise Therapy

Primary outcome

Disease specific Quality of Life
Time frame: 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.
Maximum Walking Distance
Time frame: 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.

6 secondary outcomes

Painfree Walking Distance
Time frame: 12 months
Functional Status
Time frame: 12 months
Generic Quality of Life
Time frame: 12 months
Complications
Time frame: During 12 months
Treatment failures
Time frame: During 12 months
Costs
Time frame: During 12 months

Results and safety

The study was stopped early (reason given: Study terminated after 240 patients because of slow accrual and lack of additional funding). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
Derived from this study: PubMed 23313183Frans 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.
Derived from this study: PubMed 22326696Frans 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.

Related trials for Intermittent Claudication

Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Recruiting
Passive Calf Stretching Therapy in Peripheral Artery Disease
Peripheral Artery Disease, Claudication, Intermittent

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark JW Koelemay, M.D., Ph.D principal investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Jim A Reekers, M.D., Ph.D. principal investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Dink A Legemate, M.D.,Ph.D. principal investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study terminated after 240 patients because of slow accrual and lack of additional funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease specific Quality of Life (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01385774, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.