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

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ClinicalTrials.gov Identifier: NCT00916279
Recruitment Status : Completed
First Posted : June 9, 2009
Results First Posted : December 21, 2015
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
In-Stent Restenosis Device: Lutonix Paclitaxel-Coated Balloon Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis Within Bare-Metal Stents
Study Start Date : June 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lutonix Catheter Device: Lutonix Paclitaxel-Coated Balloon
PTCA
Other Name: Drug Coated Balloon



Primary Outcome Measures :
  1. Percent Diameter Stenosis (%DS) in the Analysis Segment [ Time Frame: 6 months ]
  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Binary Restenosis [ Time Frame: 6 Months ]
    Subjects with percent diameter stenosis >50% in the analysis segment.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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;

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 ClinicalTrials.gov identifier (NCT number): NCT00916279


Locations
Belgium
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium, 9300
Germany
Kerckhoff Klinik
Bad Nauheim, Germany, 61231
Westdeutsches Herzzentrum Essen
Essen, Germany
Alte Clinic Center for Cardiology
Hamburg, Germany, 22527
Herzzentrum Leipzig GmbH
Leipzig, Germany
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Catherina Ziekenhuis
Eindhoven, Netherlands
Sint Antonius Ziehenhuis
Nieuwegein, Netherlands
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Laura Mauri, MD Brigham & Women's Hospital, Boston, MA

Publications:

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00916279     History of Changes
Other Study ID Numbers: CL0010-01
First Posted: June 9, 2009    Key Record Dates
Results First Posted: December 21, 2015
Last Update Posted: February 27, 2017
Last Verified: January 2017

Keywords provided by C. R. Bard:
Bare Metal In-Stent Restenosis
Paclitaxel Coated Balloon Catheter
Drug Coated Balloon
Coronary Artery Disease

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action