Status:
COMPLETED
De Novo Pilot Study, Lutonix Catheter in Conjunction With Bare Metal Stenting for Treatment of Coronary De Novo Lesions
Lead Sponsor:
C. R. Bard
Conditions:
Coronary Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The study will enroll patients with angiographically significant coronary de novo lesions. Subjects will be randomized 1:1 and treated with a Lutonix catheter either before or after bare-metal stentin...
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;
- Left ventricular ejection fraction (LVEF) ≥ 25%;
- Patient is an acceptable candidate for PTCA, stenting, and emergent coronary artery bypass grafting (CABG);
- Patient is willing to provide informed consent and comply with follow-up visits and testing schedule;
- Target lesion is a de novo lesion in a native coronary artery vessel;
- Initial stenosis is ≥ 50% and \< 100% by visual estimate or quantitative coronary angiography (QCA);
- Reference Vessel Diameter (RVD) is ≥ 2.5 and ≤ 3.25 prior to predilation;
- Target lesion is ≤18mm in length and can be treated in its entirety by no more than 1 single Lutonix Catheter balloon and 1 single BMS;
- Guidewire is able to cross lesion and be placed in distal vessel prior to enrollment;
- Enrollment permitted after successful treatment of 1 non-study lesion in a single other non-study vessel (not in the same vascular territory as the study lesion). Successful treatment is defined as ≤ 30% residual stenosis with Thrombolysis in Myocardial Infarction (TIMI) Grade III flow and not evidence of dissection.
Exclusion
- History of stroke within past 6 months;
- History of myocardial infarction (MI) or thrombolysis within 72 hours of randomization;
- Prior vascular brachytherapy;
- Uncontrollable allergies to procedure medications, materials or contrast;
- 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 planned to be treated with something other than PTCA and stent (i.e., cutting-balloon, atherectomy, vascular brachytherapy (VBT), etc.);
- Target lesion is in the Left Main and has excessive calcification or tortuosity or involves bifurcation disease of vessel ≥ 2.5mm;
- Known sensitivity or has received paclitaxel or other antimitogenic agent within 12 months prior to target vessel treatment;
- Patient has any previous intervention (PTCA, stent, etc.) of the target coronary vessel;
- Any medical condition, in the investigators opinion, that should preclude the patient from the study or patient has a life expectancy less than 24 months;
- Known creatine kinase-MB (CKMB) \> 2x upper limit of normal (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 antiplatelet therapy or it will need to be withdrawn for a planned procedure;
- The subject is currently participating in another investigational drug or device study.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00934752
Start Date
July 1 2009
End Date
January 1 2012
Last Update
January 16 2017
Active Locations (3)
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1
Academic Medical Center
Amsterdam, Netherlands
2
Catherina Zeikenhuis
Eindhoven, Netherlands
3
Thorax Center
Rotterdam, Netherlands