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

NCT01385774 | Terminated DMC

• 2 other identifiers: 171102025;ZonMw09/285;METC AMC
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 15

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.

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Keywords

Intermittent Claudication; Percutaneous Transluminal Angioplasty; Supervised Exercise Therapy; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Secondary Outcomes (6)

• Painfree Walking Distance

  12 months

• Functional Status

  12 months

• Generic Quality of Life

  12 months

• Complications

  During 12 months

• Treatment failures

  During 12 months

Study Arms (2)

Intervention group: Angioplasty

ACTIVE COMPARATOR

Angioplasty with or without stent of the iliac artery

Procedure: Percutaneous Transluminal Angioplasty

Control: Supervised Exercise Therapy

ACTIVE COMPARATOR

Supervised exercise therapy by a physiotherapist

Other: Supervised Exercise Therapy

Interventions

Percutaneous Transluminal Angioplasty PROCEDURE

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.

Also known as: Endovascular treatment

Intervention group: Angioplasty

Supervised Exercise Therapy OTHER

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.

Also known as: Conservative treatment

Control: Supervised Exercise Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• M.J.W. Koelemaij: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (15)

Flevoziekenhuis

Almere Stad, 1315 RA, Netherlands

Location

Sint Lucas Andreas Ziekenhuis

Amsterdam, 1061 AE, Netherlands

Location

VU Medical Center

Amsterdam, 1081 HV, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 AC, Netherlands

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

Gelre ziekenhuizen

Apeldoorn, 7334 DZ, Netherlands

Location

Ziekenhuis Rijnstate

Arnhem, 6815 AD, Netherlands

Location

Rode Kruis Ziekenhuis

Beverwijk, 1942 LE, Netherlands

Location

Deventer Ziekenhuis

Deventer, 7416 SE, Netherlands

Location

Kennemer Gasthuis

Haarlem, 2035 RC, Netherlands

Location

Tergooiziekenhuizen

Hilversum, 1213 XZ, Netherlands

Location

Spaarne Ziekenhuis

Hoofddorp, 2134 TM, Netherlands

Location

St Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

UMC St. Radboud

Nijmegen, 6525 GA, Netherlands

Location

Waterland ziekenhuis

Purmerend, 1441 RN, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 23313183 DERIVED

• 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.

  PMID: 22326696 DERIVED

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Interventions

Angioplasty; Conservative Treatment

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

• Shandra Bipat, Ph.D.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 30, 2011
• Study Start: November 1, 2010
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

NL (15)