This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.
This is an observational, prospective, consecutively enrolled, single-arm, multi-site registry of the use of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease. This study covers the use of endovascular devices including the DABRA Laser System and other devices commercially used in the United States for the treatment of lower extremity PAD.
Study Type
OBSERVATIONAL
Enrollment
19
PAD endovascular treatment using the DABRA Laser System + other FDA cleared/ approved devices for the treatment of PAD.
NAADI Healthcare
Oklahoma City, Oklahoma, United States
Vessel Patency
Patency of the target lesion at 24 months, as determined by duplex ultrasound.
Time frame: 24 months
Serious Adverse Events
Tabulation of serious adverse events at 1 day, 6 months, 12 months, 18 months, and 24 months
Time frame: 1 day, 6 months, 12 months, 18 months, and 24 months
Vessel Patency
Patency of the target lesion at 6 months, 12 months, and 18 months, as determined by duplex ultrasound.
Time frame: 6 months, 12 months, and 18 months
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