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

Mego Afek

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Device: AngioPress Intermittent pneumatic compression (IPC) Device

Other: Medications and Standard walking exercises

Study type

Interventional

Funder types

Industry

Identifiers

NCT00762086

HM-AHR-01

Details and patient eligibility

About

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

Full description

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.

Enrollment

67 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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