PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis (PERVIDEO I)

January 12, 2017 updated by: C. R. Bard

A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis Within Bare-Metal Stents

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 investigate the feasibility, safety, and efficacy of the Lutonix Catheter in the native coronary system. Angiographic and clinical outcomes will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

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

  • Belgium
      • Aalst, Belgium, 9300
        • Onze Lieve Vrouw Ziekenhuis
  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff Klinik
      • Essen, Germany
        • Westdeutsches Herzzentrum Essen
      • Hamburg, Germany, 22527
        • Alte Clinic Center for Cardiology
      • Leipzig, Germany
        • Herzzentrum Leipzig GmbH
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center
      • Eindhoven, Netherlands
        • Catherina Ziekenhuis
      • Nieuwegein, Netherlands
        • Sint Antonius Ziehenhuis

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;
  • 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 Criteria:

  • 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;

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
PTCA
Other Names:
  • Drug Coated Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Diameter Stenosis (%DS) in the Analysis Segment
Time Frame: 6 months
6 months
Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months
Time Frame: 6 Months
Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late Lumen Loss
Time Frame: 6 months
Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal).
6 months
MACE Rate
Time Frame: 30 Days
Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).
30 Days
Binary Restenosis
Time Frame: 6 Months
Subjects with percent diameter stenosis >50% in the analysis segment.
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: Laura Mauri, MD, Brigham & Women's Hospital, Boston, MA

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

June 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL0010-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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