N/A
Completed N=1,005
Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter
Peripheral arterial disease · Peripheral Vascular Diseases · Arterial Occlusive Diseases
Source: ClinicalTrials.gov NCT02424383 ↗
Enrolled (actual)
1,005
Serious AEs
6.5%
Results posted
May 2020
Primary outcomePrimary: Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure — 88.6 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure |
88.6 | — |
| PRIMARY 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 |
98.2 | — |
| SECONDARY Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure |
94.7; 86.5; 75.7; 69.5 | — |
| SECONDARY Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure. |
95.9; 79.8; 74.4 | — |
| SECONDARY Percentage of Participants With Acute Device and Procedural Success |
93.0 | — |
| SECONDARY Percentage of Participants With Primary Patency at 12 Months Post Index Procedure |
83.7 | — |
| SECONDARY 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 |
90.3; 80.8; 67.4; 58.4 | — |
| SECONDARY 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. |
98.5; 97.5; 96.6; 95.6 | — |
Eligibility Criteria
Inclusion Criteria
- The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site.
- The subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- The subject is ≥ 21 years old.
- The subject must have a lesion(s) that can be treated with available Lutonix 035 DCB Catheter according to IFU.
Exclusion Criteria
- The subject is unable or unwilling to provide informed consent.
- The subject is unable or unwilling to comply with the patient registry protocol follow-up procedures and visits.
- The subject has another medical condition or is currently participating in an investigational drug or an investigational device study that, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confounds the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of patient registry procedures and follow-up.
Data sourced from ClinicalTrials.gov (NCT02424383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.