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

January 13, 2017 updated by: C. R. Bard

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center
      • Eindhoven, Netherlands
        • Catherina Zeikenhuis
      • Rotterdam, Netherlands
        • Thorax Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lutonix Catheter
Device: Lutonix Paclitaxel-Coated Balloon
Percutaneous transluminal coronary angioplasty (PCTA)
Other Names:
  • Drug Coated Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean percent stent volume obstruction as measured by optical coherence tomography (OCT)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Stent Malposition
Time Frame: 6 Months
6 Months
Minimal Lumen Area
Time Frame: 6 Months
6 Months
Stent Symmetry
Time Frame: 6 Months
6 Months
Stent Expansion
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. R. Bard

Investigators

  • Principal Investigator: Prof. P.W.J C. Serruys, MD, PhD, Erasmus Universtiy Medical Center; Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL0013-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Stenosis

Clinical Trials on Lutonix Paclitaxel-Coated Balloon

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe