Status:
COMPLETED
PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis
Lead Sponsor:
C. R. Bard
Conditions:
In-Stent Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 investigat...
Eligibility Criteria
Inclusion
- 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 \<100% by visual estimate or QCA prior to defined pre-dilatation;
- Reference Vessel Diameter (RVD) is ≥2.5 and ≤3.25;
- Target lesion is ≤40 mm in length and can be treated in its entirety by no more than 2 contiguous Lutonix Catheters;
- Guidewire is able to cross lesion(s) and be placed in distal vessel prior to enrollment;
- Enrollment permitted after successful treatment of 1 to 2 non-study lesions in a single other non-study vessel. Successful treatment is defined as ≤30% residual stenosis with TIMI III flow and no evidence of dissection.
Exclusion
- History of Stroke within past 6 months;
- History of MI or thrombolysis within 72 hours of randomization;
- History of previous target vessel perforation;
- Prior vascular brachytherapy;
- Angiographic evidence of thrombus or dissection within the target vessel;
- Intervention of another coronary lesion \<60 days before index procedure day or planned following index procedure;
- Target lesion is in the Left Main or vessel ostium and has excessive calcification or tortuosity or involves bifurcation disease of vessel ≥2.5 mm;
- Target lesion is planned to be treated with something other than PTCA (i.e. stent, cutting balloon, atherectomy, VBT, etc.);
- Uncontrollable allergies to procedure medications, materials, or contrast;
- Patient has previous stent procedure with any drug-coated or drug eluting stent device in the target coronary vessel;
- Known sensitivity to paclitaxel or other antimitogenic agent;
- Patient has a stent sandwich (a stench previously deployed within another stent;
- Pre-procedure CKMB \>2x ULN or positive Troponin;
- Creatinine \>2.0 mg/dl;
- Leukocyte \<3500/mL;
- Platelet \<100,000 mL or \>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;
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00916279
Start Date
June 1 2009
End Date
December 1 2011
Last Update
February 27 2017
Active Locations (8)
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1
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium, 9300
2
Kerckhoff Klinik
Bad Nauheim, Germany, 61231
3
Westdeutsches Herzzentrum Essen
Essen, Germany
4
Alte Clinic Center for Cardiology
Hamburg, Germany, 22527