N/A
N=82
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
Femoral Artery Stenosis · Femoral Artery Occlusion · Restenosis
Bottom Line
View on ClinicalTrials.gov: NCT02063672 ↗Enrolled (actual)
82
Serious AEs
74.4%
Results posted
May 2018
Primary outcome: Primary: Percentage of Participants With Primary Patency at 1 Year — 67.0; 49.5 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lutonix DCB (Device); Standard Uncoated Balloon Angioplasty Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Primary Patency at 1 Year |
67.0; 49.5 | — |
| PRIMARY Percentage of Participants Without Primary Safety Events |
72.8; 64.0 | — |
| SECONDARY Percentage of Participants With Device Success |
98.1; 100 | — |
| SECONDARY Percentage of Participants With Technical Success |
66.0; 77.8 | — |
| SECONDARY Percentage of Participants With Procedural Success |
70.0; 77.8 | — |
| SECONDARY Percentage of Participants With Primary Patency at 6 and 12 Months |
92.1; 77.0; 67.0; 37.1 | — |
| SECONDARY Percentage of Participants With Secondary Patency at 6 Months and 12 Months |
90.9; 60.0; 74.2; 80.0 | — |
| SECONDARY Percentage of Participants Without Clinically Driven Target Lesion Revascularization (TLR) |
94.3; 96.4; 78.6; 64.0 | — |
| SECONDARY Percentage of Participants Without Target Lesion Revascularization (TLR) |
94.3; 92.7; 78.6; 64.0 | — |
| SECONDARY Percentage of Participants With Sustained Clinical Benefit Compared to Baseline |
69.4; 59.1; 61.2; 50.0 | — |
| SECONDARY Change of Rutherford Classification From Baseline |
-1.7; -1.5; -1.6; -1.9 | — |
| SECONDARY Change of Resting Ankle Brachial Index (ABI) From Baseline |
0.20; 0.25; 0.16; 0.16 | — |
| SECONDARY Change in Walking Impairment Questionnaire From Baseline |
14.9; 16.0; 12.7; 12.7 | — |
| SECONDARY Change in Quality of Life From Baseline |
0.1; 0.0; 0.0; 0.0; -2.0; 0.3 | — |
| SECONDARY Percentage of Participants Without Major Vascular Complications (≤30 Day) |
98.1; 92.9 | — |
| SECONDARY Percentage of Participants Without All-Cause Death |
100; 100; 100; 96.4; 100; 96.4 | — |
| SECONDARY Percentage of Participants Without Major Limb Amputation |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Percentage of Participants Without Minor Limb Amputation |
100; 100; 100; 96.4; 100; 96.4 | — |
| SECONDARY Percentage of Participants Without Target Vessel Revascularizations (TVR) |
96.2; 100; 90.5; 92.7; 76.7; 64.0 | — |
| SECONDARY Percentage of Participants Without Any Target Limb Reinterventions |
96.2; 100; 88.5; 92.7; 72.8; 64.0 | — |
Summary
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
Eligibility Criteria
Key Inclusion Criteria
- Male or non-pregnant female ≥18 years of age
- Rutherford Clinical Category 2-4
- Significant (≥ 50%) restenosis of a previous bare (not covered and not drug-eluting) nitinol stent(s) in the femoropopliteal artery
- Lesion measures between 4 and 18 cm
- Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix
- A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography
- Successful crossing and predilatation of the target lesion with a guidewire
- At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been (nor planned to be) revascularized
- No other prior vascular or surgical interventions within 2 weeks before and/or planned 30 days after the protocol treatment
Key Exclusion Criteria
- Life expectancy of 50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion
- Intended use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, stents, etc.)
Data sourced from ClinicalTrials.gov (NCT02063672). 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.