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

Not Applicable

Terminated

• Conditions: Intermittent Claudication; Peripheral Arterial Disease
• Interventions: Procedure: Percutaneous Transluminal Angioplasty; Other: Supervised Exercise Therapy

• Registration Number: NCT01385774
• Lead Sponsor: M.J.W. Koelemaij

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 240

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group: Angioplasty	Percutaneous Transluminal Angioplasty	Angioplasty with or without stent of the iliac artery
Control: Supervised Exercise Therapy	Supervised Exercise Therapy	Supervised exercise therapy by a physiotherapist

Primary Outcome Measures

Name	Time	Method
Maximum Walking Distance	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.
Disease specific Quality of Life	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.

Secondary Outcome Measures

Name	Time	Method
Complications	During 12 months	Complications related to both interventions during 12 months.
Treatment failures	During 12 months	A treatment failure is defined as crossover to the other treatment arm.
Painfree Walking Distance	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.
Generic Quality of Life	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.
Functional Status	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.
Costs	During 12 months	Costs during 1 year.

Trial Locations

Locations (15)

VU Medical Center; 🇳🇱 Amsterdam, Netherlands

Gelre ziekenhuizen; 🇳🇱 Apeldoorn, Netherlands

Tergooiziekenhuizen; 🇳🇱 Hilversum, Netherlands

UMC St. Radboud; 🇳🇱 Nijmegen, Netherlands

Flevoziekenhuis; 🇳🇱 Almere, Netherlands

Sint Lucas Andreas Ziekenhuis; 🇳🇱 Amsterdam, Netherlands

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Ziekenhuis Rijnstate; 🇳🇱 Arnhem, Netherlands

Rode Kruis Ziekenhuis; 🇳🇱 Beverwijk, Netherlands

Deventer Ziekenhuis; 🇳🇱 Deventer, Netherlands

Kennemer Gasthuis; 🇳🇱 Haarlem, Netherlands

Spaarne Ziekenhuis; 🇳🇱 Hoofddorp, Netherlands

St Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Waterland ziekenhuis; 🇳🇱 Purmerend, Netherlands