Trial Outcomes & Findings for Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II (NCT NCT00762086)

NCT ID: NCT00762086

Last Updated: 2012-08-31

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 67 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2012-08-31

Participant Flow

Between March 2009 and August 2011, a total of 67 patients were screened and randomized into the study. Patients were recruited from private clinics and clinics affiliated to University Hospitals

Subjects were required to be treated with Aspirin/Clopidogrel for at least one week priot to 1st treatment

Participant milestones

Measure	Treatment Group AngioPress IPC Device	Control Group Aspirin/Clopidegrol and Standard walking exercises
Overall Study STARTED	39	28
Overall Study COMPLETED	33	24
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Measure	Treatment Group AngioPress IPC Device	Control Group Aspirin/Clopidegrol and Standard walking exercises
Overall Study Adverse Event	2	0
Overall Study Lost to Follow-up	0	2
Overall Study Non compliance	1	0
Overall Study Withdrawal by Subject	2	2
Overall Study Ineligible to participate in the study	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment Group n=39 Participants AngioPress IPC Device	Control Group n=28 Participants Aspirin/Clopidegrol and Standard walking exercises	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants	17 Participants n=7 Participants	45 Participants n=5 Participants
Age Continuous	70.8 years STANDARD_DEVIATION 6.96 • n=5 Participants	67.8 years STANDARD_DEVIATION 11.76 • n=7 Participants	69.5 years STANDARD_DEVIATION 9.31 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment Israel	25 participants n=5 Participants	23 participants n=7 Participants	48 participants n=5 Participants
Region of Enrollment Germany	14 participants n=5 Participants	5 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: ITT cohort

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

Outcome measures

Measure	Treatment Group n=39 Participants AngioPress IPC Device	Control Group n=28 Participants Aspirin/Clopidegrol and Standard walking exercises
Absolute Claudication Distance (ACD)	54.374 Meters Standard Error 15.3752	0.792 Meters Standard Error 18.0868

Adverse Events

Treatment Group

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Group n=39 participants at risk AngioPress IPC Device	Control Group n=28 participants at risk Aspirin/Clopidegrol and Standard walking exercises
Cardiac disorders Hypertensive Crisis	2.6% 1/39 • Number of events 1	0.00% 0/28
Cardiac disorders Congestive heart failure	2.6% 1/39 • Number of events 1	0.00% 0/28

Other adverse events

Measure	Treatment Group n=39 participants at risk AngioPress IPC Device	Control Group n=28 participants at risk Aspirin/Clopidegrol and Standard walking exercises
General disorders Application site discomfort	5.1% 2/39 • Number of events 2	0.00% 0/28

Additional Information

Shmulik Adler

A. Stein Regulatory Affairs Consulting

Phone: 972-9-767-0002

Email: shmulik@asteinrac.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place