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Drug Coated Balloon Catheter

PTA (Lutonix® 035 DCB Catheter) for Peripheral Arterial Disease (SAFE-DCB Trial)

N/A
Waitlist Available
Led By Nicholas Shammas, MD
Research Sponsored by C. R. Bard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 , 12, 24, and 36 months
Awards & highlights

Summary

The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.

Eligible Conditions
  • Peripheral Arterial Disease
  • Peripheral Vascular Disease
  • Arterial Occlusive Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 , 12, 24, and 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 , 12, 24, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Freedom From Composite of Device and/or Procedure Related Perioperative Death, Target Limb Major Amputation (Above the Ankle), and Target Vessel Revascularization) at 30 Days Post Index Procedure
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure
Secondary study objectives
Percentage of Participants With Acute Device and Procedural Success
Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure
Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure.
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PTA (Lutonix® 035 DCB Catheter)Experimental Treatment1 Intervention
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PTA (Lutonix® 035 DCB Catheter)
2015
N/A
~1010

Find a Location

Who is running the clinical trial?

C. R. BardLead Sponsor
103 Previous Clinical Trials
38,595 Total Patients Enrolled
18 Trials studying Peripheral Arterial Disease
6,401 Patients Enrolled for Peripheral Arterial Disease
Nicholas Shammas, MDPrincipal InvestigatorMidwest Cardiovascular Research Foundation
Edward Woo, MDPrincipal InvestigatorMedStar Regional
~96 spots leftby Oct 2025
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