Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated balloon or standard uncoated balloon angioplasty: a structured protocol summary of the “SirPAD” randomized controlled trial
DiscussionBy focusing on clinically relevant outcomes, this study will provide useful information on the efficacy and safety of sirolimus-coated balloon catheters for infra-inguinal peripheral arterial disease in a representative ( “all-comer”) population of unselected patients. As regulatory agencies had raised safety concerns in patients exposed to paclitaxel-coated devices (versus uncoated ones), collect mortality data up to 5 years after randomization will be collected.Trial registrationClinicalTrials.govNCT04238546 (Source: Trials)
Source: Trials - April 21, 2022 Category: Research Source Type: clinical trials

A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease: a Pilot Study
Conditions:   Peripheral Arterial Disease;   Intermittent Claudication Intervention:   Device: Home-based leg heat therapy Sponsors:   Purdue University;   Aquilo Sports Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 19, 2022 Category: Research Source Type: clinical trials

WalkingPad protocol: a randomized clinical trial of behavioral and motivational intervention added to smartphone-enabled supervised home-based exercise in patients with peripheral arterial disease and intermittent claudication
This study will allow measuring  the effectiveness of an m-health tool in increasing motivation for behavior change and adherence to an HBET program in patients with PAD. The superiority of experimental group 2 in the primary and secondary outcomes will indicate that the virtual assistant is effective for motivating behavioral c hange and encouraging the practice and adherence to physical exercise. The use of m-health tools and virtual health assistants can potentially fill a gap in the access and quality of health services and information, reducing the burden on the health system and promoting self-management and self-c...
Source: Trials - April 18, 2022 Category: Research Source Type: clinical trials

Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD
Conditions:   Peripheral Arterial Disease;   Intermittent Claudication;   Behavior, Health;   Exercise Intervention Intervention:   Behavioral: Exercise and Lifestyle Change Sponsor:   Northumbria University Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 2, 2022 Category: Research Source Type: clinical trials