De Novo Pilot Study, Lutonix Catheter in Conjunction With Bare Metal Stenting for Treatment of Coronary De Novo Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00934752
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : January 16, 2017
Information provided by (Responsible Party):
C. R. Bard

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 stenting (BMS). The purpose is to assess the feasibility, safety and efficacy of the Lutonix Catheter for treatment of de novo coronary artery stenosis using two distinct treatment strategies.

Condition or disease Intervention/treatment Phase
Coronary Artery Stenosis Device: Lutonix Paclitaxel-Coated Balloon Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study Investigating the Use of the Lutonix Paclitaxel-Coated Balloon in Conjunction With Bare Metal Stenting in Patients With De Novo Coronary Lesions.
Study Start Date : July 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Lutonix Catheter Device: Lutonix Paclitaxel-Coated Balloon
Percutaneous transluminal coronary angioplasty (PCTA)
Other Name: Drug Coated Balloon

Primary Outcome Measures :
  1. Mean percent stent volume obstruction as measured by optical coherence tomography (OCT) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Stent Malposition [ Time Frame: 6 Months ]
  2. Minimal Lumen Area [ Time Frame: 6 Months ]
  3. Stent Symmetry [ Time Frame: 6 Months ]
  4. Stent Expansion [ Time Frame: 6 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;
  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00934752

Academic Medical Center
Amsterdam, Netherlands
Catherina Zeikenhuis
Eindhoven, Netherlands
Thorax Center
Rotterdam, Netherlands
Sponsors and Collaborators
C. R. Bard
Principal Investigator: Prof. P.W.J C. Serruys, MD, PhD Erasmus Universtiy Medical Center; Netherlands

Publications of Results:
Other Publications:

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: C. R. Bard Identifier: NCT00934752     History of Changes
Other Study ID Numbers: CL0013-01
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017

Keywords provided by C. R. Bard:
de novo stenotic lesions

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action