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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00934752
First received: July 6, 2009
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Coronary Artery Stenosis
Device: Lutonix Paclitaxel-Coated Balloon
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Mean percent stent volume obstruction as measured by OCT [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Stent Malaposition [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Minimal Lumen Area [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Stent Symmetry [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Stent Expansion [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: July 2009
Study Completion Date: January 2012
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lutonix Catheter Device: Lutonix Paclitaxel-Coated Balloon
Percutaneous transluminal coronary angioplasty (PCTA)
Other Name: Drug Coated Balloon

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 CCSC 1-4, unstable angina pectoris with documented ischemia (Braunwald I-II) or documented silent ischemia;
  • 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 a de novo lesion in a native coronary artery vessel;
  • Initial stenosis is ≥ 50% and < 100% by visual estimate or 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 TIMI III flow and not evidence of dissection.

Exclusion Criteria:

  • History of stroke within past 6 months;
  • History of 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, 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 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934752

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00934752     History of Changes
Other Study ID Numbers: CL0013-01
Study First Received: July 6, 2009
Last Updated: April 16, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014