REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)
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|ClinicalTrials.gov Identifier: NCT04010045|
Recruitment Status : Active, not recruiting
First Posted : July 8, 2019
Last Update Posted : September 9, 2020
|Condition or disease||Intervention/treatment|
|Peripheral Artery Disease||Device: Endovascular Treatment of PAD|
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|
|Estimated Enrollment :||2500 participants|
|Official Title:||REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)|
|Actual Study Start Date :||May 2, 2019|
|Estimated Primary Completion Date :||November 30, 2023|
|Estimated Study Completion Date :||November 30, 2025|
- Device: Endovascular Treatment of PAD
PAD endovascular treatment using the DABRA Laser System + other FDA cleared/ approved devices for the treatment of PAD.Other Name: PAD endovascular treatment using the DABRA Laser System
- Vessel Patency [ Time Frame: 24 months ]Patency of the target lesion at 24 months, as determined by duplex ultrasound.
- Serious Adverse Events [ Time Frame: 1 day, 6 months, 12 months, 18 months, and 24 months ]Tabulation of serious adverse events at 1 day, 6 months, 12 months, 18 months, and 24 months
- Vessel Patency [ Time Frame: 6 months, 12 months, and 18 months ]Patency of the target lesion at 6 months, 12 months, and 18 months, as determined by duplex ultrasound.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010045
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 73116|
|Study Director:||Jami Miller||Ra Medical Systems|