Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of new intermittent pneumatic compression device on initial claudication distance in patients with Peripheral Arterial Disease stage II

Detailed Description
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Patients with Peripheral Arterial Disease (PAD) suffer from symptoms such as intermittent claudication, limb and foot pain and tissue lesions, which are difficult to treat. In recent years, there have been reports demonstrating reduction of these symptoms by use of compressible sleeve devices. This clinical study aims at demonstrating the safety and effectiveness of this device in treating PAD symptoms.

Official Title
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A Prospective, Randomized, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of a New Intermittent Pneumatic Compression Device on Initial Claudication Distance in Patients With Peripheral Arterial Disease Stage II.

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: AngioPress Intermittent pneumatic compression (IPC) Device
* Other: Medications and Standard walking exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subject 18 to 90 years, of any race. Patients with proven Peripheral Arterial Disease (PAD) in Doppler Ultrasound and Ankle-Brachial Pressure Index (ABPI ≤ 0.9 in one leg) Subject with stable (>3 month) PAD Fontaine Stage II. Aortoiliac vessels with no significant hemodynamic disturbances , as confirmed by recent (<30 days) clinical examination Subject has intermittent claudication and claudication pain of the calf Subject has stable intermittent claudication (>3 month and not more than one year) with initial claudication distance not more than 250 meters, as determined by treadmill test (3.2 km/h, 10% grade) Subject willing to participate as evidenced by signing the written informed consent. Treatment with Aspirin or Clopidogrel for at least 7 days Willingness to undergo standardized walking exercise Exclusion Criteria: Ankle-Brachial Pressure Index (ABI) above 0.8 in both legs. In Diabetic patients with no compressible arteries ABI above 40 mm/Hg of the higher pressure measured in both arms. Inability to walk Chronic respiratory insufficiency (severe obstructive or restrictive) Coronary artery disease with angina Stroke, myocardial infarction or other acute vascular events in the last 3 months Mild-Severe congestive heart failure Degenerative or inflammatory hip, knee, ankle or foot joint lesions interfering with walking Spinal stenosis or disc lesions with lower limb motor sensory defects Leg trauma, limb or skin infection or edema Recent (6 months) abdominal, cardiothoracic, vascular or orthopedic (lower limb) surgery Subject after crural or pedal bypass surgery Subject with neuropathy Uncontrolled arterial hypertension Morbid obesity (BMI >35.0) Need for concomitant medication with potential vascular activity Routinely use of pain relief medications (i.e. NSAIDs, Narcotics etc) Expected weak compliance Subject requires surgical or endovascular intervention for PAD Subject has known allergy to device components (sleeve fabric). Subject has medical conditions that may be worsened by concomitant use of the device (i.e. recent (1 year) Deep Vein Thrombosis). Subject participates in any other clinical study at the same time

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group<br>AngioPress Intermittent pneumatic compression (IPC) Device | Device: AngioPress Intermittent pneumatic compression (IPC) Device<br>* Treatment with Intermittent pneumatic compression (IPC) for PAD<br>|
| Other: Control Group<br>Aspirin/Clopidegrol and Standard walking exercises | Other: Medications and Standard walking exercises<br>* Aspirin/Clopidegrol and Standard walking exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Claudication Distance (ACD) | Absolute walking distance is measured by walking on a treadmill until the point when the subject is inable to walk anymore due to pain in the leg. The walking distance is measured by meters | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, intermittent pneumatic compression treatment, Initial claudication