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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Iliac, Common and External (ICE) Artery Stent Trial

NCT01305174

Vascular Lesions

TERMINATED PHASE4

Self Expanding Nitinol Stent Versus Percutaneous Transluminal Arterial Angioplasty (PTA) With Optional Bailout Stenting in Case of PTA Failure in Patients With Symptomatic Critical Limb Ischemia or Severe Intermittent Claudication (EXPAND)

NCT00906022

Patients With Symptomatic Critical Limb Ischemia Severe Intermittent Claudication

COMPLETED PHASE4

Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease

NCT04475783

Peripheral Artery Disease

ACTIVE_NOT_RECRUITING NA

Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome

NCT05744843

Post Thrombotic Syndrome

RECRUITING NA

Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions

NCT06112171

Peripheral Arterial Disease

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Intermittent Claudication Peripheral Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group: Angioplasty

Angioplasty with or without stent of the iliac artery

Group Type ACTIVE_COMPARATOR

Percutaneous Transluminal Angioplasty

Intervention Type 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.

Control: Supervised Exercise Therapy

Supervised exercise therapy by a physiotherapist

Group Type ACTIVE_COMPARATOR

Supervised Exercise Therapy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Endovascular treatment Conservative treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No