PIONIR Study (Presillion™ and Presillion™ Plus Stent Systems)

March 25, 2018 updated by: Medinol Ltd.

Clinical Protocol Presillion™ and Presillion™ Plus Stent Systems

The purpose of this study is to collect and analyze additional information about the safety and effectiveness of the Presillion™ Stent System in the treatment of de novo stenotic lesions in native coronary arteries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a post market, non-randomized, multi-center, prospective, single arm clinical study that will be conducted at up to 25 sites in Europe and Israel. All patients will be followed at 30 days, 6 months, 9 months and 1 year post index stenting procedure.

The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the Presillion™ Stent System. This rate will be compared with a performance goal derived using a meta-analysis of the standard-of-care therapy, coronary stenting with bare metal stents. This data will be used to support the PMA application for the Presillion™ Stent System.

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 4

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
      • Antwerpen, Belgium, 2020
        • ZNA Middelheim
      • Brussels, Belgium, 1090
        • UZ Brussel
      • Charleroi, Belgium, 6000
        • CHU Charleroi
      • Liege, Belgium, 4000
        • CHU de Liege
  • Germany
      • Bad Segeberg, Germany, D-23795
        • Herz-Kreislauf-Zentrum Segeberger Kliniken
      • Berlin, Germany, 12203
        • Charite - Campus Benjamin Franklin
      • Frankfurt, Germany, 60389
        • Cardiovascular Center Frankfurt Sankt katharinen
      • Heidelberg, Germany, 69120
        • university Hospital of Heidelberg
      • Siegburg, Germany, 53721
        • Helios Klinkum
      • Villingen-Schwenningen, Germany, D 78050
        • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
  • Israel
      • Afula, Israel, 18101
        • Emek Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization
      • Netanya, Israel, 42150
        • Sanz Medical Center, Laniado Hospital
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center
  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
      • Lund, Sweden
        • Lund University Hospital

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:

  1. Patient >= 18 years old.
  2. Eligible for Percutaneous Coronary Intervention (PCI).
  3. Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
  4. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
  5. Acceptable candidate for coronary artery bypass graft (CABG) surgery.
  6. Stable angina pectoris (Canadian Cardiovascular Society (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ETT, SPECT, Stress echocardiography or Cardiac CT).
  7. Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).

Exclusion Criteria:

  1. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
  2. Previously enrolled in another stent trial in the previous 2 years.
  3. ANY planned elective surgery or percutaneous intervention within subsequent 9 months.
  4. A previous coronary interventional procedure of any kind within the 30 days prior to the procedure.
  5. The subject requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
  6. Previous drug eluting stent (DES) deployment anywhere in the target vessel.
  7. Any drug eluting stent (DES) deployment anywhere within the past 12 months
  8. Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
  9. Concurrent medical condition with a life expectancy of less than 12 months.
  10. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Presillion™ Stent System
Device: Catheterization, stent deployment
Standard catheterization procedure including Bare Metal Stent deployment.
Other Names:
  • CoCr Coronary Stent
  • Coronary Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Target vessel failure (TVF)
Time Frame: 270 days
270 days

Collaborators and Investigators

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

Sponsor

Medinol Ltd.

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.

Helpful Links

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

April 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 25, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV103-01

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.

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