Phase 2
N=41
PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis
In-Stent Restenosis
Bottom Line
View on ClinicalTrials.gov: NCT00916279 ↗Enrolled (actual)
41
Serious AEs
53.7%
Results posted
Dec 2015
Primary outcome: Primary: Percent Diameter Stenosis (%DS) in the Analysis Segment — 36.0 Percentage stenosis of vessel diameter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lutonix Paclitaxel-Coated Balloon (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Diameter Stenosis (%DS) in the Analysis Segment |
36.0 | — |
| PRIMARY Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months |
8.5 | — |
| SECONDARY Late Lumen Loss |
0.17 | — |
| SECONDARY MACE Rate |
— | — |
| SECONDARY Binary Restenosis |
5 | — |
Summary
The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in the native coronary system. Angiographic and clinical outcomes will be assessed.
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant/non-breast feeding Female ≥18 Years of age. Women of childbearing potential must have a negative pregnancy test within 7 days of the procedure;
- Documented stable angina pectoris Canadian Cardiovascular Society Classification (CCSC) 1-4, unstable angina pectoris with documented ischemia (Braunwald I-II) or documented silent ischemia;
- Previous history of native coronary bare metal stenting ≥60 days;
- LVEF ≥25%;
- Patient is an acceptable candidate for PTCA, stenting, and emergent CABG;
- Patient is willing to provide informed consent and comply with follow-up visits and testing schedule;
- Target lesion is in a native coronary with previous single bare metal stent; Stenosis is ≥50% and 2x ULN or positive Troponin;
- Creatinine >2.0 mg/dl;
- Leukocyte 750,000 mL;
- Currently taking or must resume warfarin;
- Patient is contraindicated for anti-platelet therapy or it will need to be withdrawn for a planned procedure;
- The patient is currently participating in another investigational drug or device study that has not completed its primary endpoint or that clinically interferes with the endpoints of this study;
Data sourced from ClinicalTrials.gov (NCT00916279). 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.