REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study

Peripheral Artery Disease Clinical Trial

— RESULTS  

Official title:

REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04010045
• Other study ID #: RMS-104
• Status: Terminated
• Start date: May 2, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: October 2021
• Source: Ra Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Participant's age = 22 years.
• Participant presents with a Rutherford category of 2 to 6.
• Participant has at least one peripheral lesion, = 140mm, in a native vessel that is treated successfully with DABRA Laser System.
• Participant is able and willing to be anti-coagulated.
• Ability and willingness of participant to give written informed consent and comply with follow-up.

Exclusion Criteria:

• Pregnant, breastfeeding, planning to become pregnant - If women of reproductive capability will be enrolled, status will be assessed via pregnancy testing. Subject must agree to use effective birth control measures for duration of study. Pregnancy during study must be reported immediately.
• Endovascular interventions within 90 days prior to study enrollment (on leg to be treated).
• Participation in another cardiovascular or peripheral vascular study that might, in the judgement of the Investigator, affect the results of the study.
• Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast.
• Inability or unwillingness of the patient to comply with study examinations.
• Necrosis necessitating major amputation.
• Subject has an anticipated life span of less than one (1) year.
• Medically non-compliant subjects, based on Investigator judgment (e.g., subject is non-compliant in following medical advice regarding blood pressure medication, cholesterol medication, and/or maintenance of healthy blood sugar levels).
• No run-off vessel is present when treating above the knee. A run-off vessel is required when treating above the knee, however, it is not required when treating below the knee.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Endovascular Treatment of PAD
PAD endovascular treatment using the DABRA Laser System + other FDA cleared/ approved devices for the treatment of PAD.

Locations

Country	Name	City	State
United States	NAADI Healthcare	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Ra Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vessel Patency	Patency of the target lesion at 24 months, as determined by duplex ultrasound.	24 months
Secondary	Serious Adverse Events	Tabulation of serious adverse events at 1 day, 6 months, 12 months, 18 months, and 24 months	1 day, 6 months, 12 months, 18 months, and 24 months
Secondary	Vessel Patency	Patency of the target lesion at 6 months, 12 months, and 18 months, as determined by duplex ultrasound.	6 months, 12 months, and 18 months