Phase 2
Completed N=41
PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis
Source: ClinicalTrials.gov NCT00916279 ↗Enrolled (actual)
41
Serious AEs
53.7%
Results posted
Dec 2015
Primary outcomePrimary: Percent Diameter Stenosis (%DS) in the Analysis Segment — 36.0 Percentage stenosis of vessel diameter
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.
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 | — |
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- Patient is contraindicated for anti-platelet therapy or it will need to be withdrawn for a planned procedure;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. Informational only — not medical advice.