NCT02653456

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the treatment of patients with lower extremity vascular disease with chronic total occlusions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 7, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 24, 2018

Completed
Last Updated

November 21, 2018

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

January 8, 2016

Results QC Date

August 27, 2018

Last Update Submit

October 23, 2018

Conditions

Peripheral Arterial Disease

Keywords

excimer laserpercutaneous catheterphotoablationchronic total occlusionsymptomatic infrainguinal lower extremity vascular disease

Outcome Measures

Primary Outcomes (1)

  • Crossing the Target Lesion

    Crossing the target lesion based on angiographic analysis

    at time of procedure

Secondary Outcomes (3)

  • Number of Participants With no Device-related Major Adverse Events

    at time of procedure, up to an hour

  • Number of Participants With Target Lesion Revascularization

    30 days

  • Number of Participants With Target Lesion Revascularization

    6 months

Study Arms (1)

RA-308 Excimer Laser and DABRA Catheter

EXPERIMENTAL

Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions that cannot be crossed with standard guidewires. The catheter and laser are a system, and cannot be used separately.

Device: RA-308 Excimer Laser and DABRA Catheter

Interventions

RA-308 Excimer Laser and DABRA CatheterDEVICE

See information already included in arm description

RA-308 Excimer Laser and DABRA Catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent
  • lesions in the superficial femoral artery (SFA), popliteal, or infrapopliteal arteries at least one angiographically identifiable infrageniculate artery
  • patients must be poor surgical candidates, indicated by at least one of the following conditions:
  • absence of venous autologous grafts (that is, lack of a suitable vein to use for bypass)
  • poor (diffusely diseased or \<=1mm diameter) or no distal vessels available for graft anastamosis
  • high risk of surgical mortality, evidenced by American Society of Anesthesiologists Physical Class 4 or higher

You may not qualify if:

  • age below 18 years
  • pregnancy, or plan to become pregnant
  • participation in another cardiovascular or peripheral vascular study
  • myocardial infarction (MI) in prior month
  • stents at treatment site
  • disorders or allergies precluding use of radiographic contrast
  • renal insufficiency sever enough to contraindicate use of radiographic contrast
  • contraindication to treatment with anticoagulants
  • untreated ipsilateral iliac stenosis \>70%
  • inability or unwillingness of the patient to comply with intended examinations
  • unavailability of required procedural or imaging equipment
  • lesion located in a graft
  • hemodynamically significant arrhythmia or left ventricular ejection fraction \<20%
  • life expectancy less than 6 months
  • necrosis necessitating major amputation
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

California Heart & Vascular Clinic

El Centro, California, 92243, United States

Location

University of California San Diego

San Diego, California, 92093, United States

Location

Merit Health Wesley

Hattiesburg, Mississippi, 39402, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Vice President of Regulatory Affairs and Quality Assurance
Organization
Ra Medical Systems, Inc.
vchester@ramed.com
877-635-1800

Study Officials

  • Ehtisham Mahmud

    UCSD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 12, 2016

Study Start

April 7, 2016

Primary Completion

May 3, 2017

Study Completion

July 14, 2017

Last Updated

November 21, 2018

Results First Posted

October 24, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)