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

This study has been completed.
Sponsor:
Information provided by:
Medinol Ltd.
ClinicalTrials.gov Identifier:
NCT00840775
First received: February 9, 2009
Last updated: August 11, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Ischemic Heart Disease
Device: Catheterization, stent deployment
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Clinical Protocol Presillion™ and Presillion™ Plus Stent Systems

Resource links provided by NLM:


Further study details as provided by Medinol Ltd.:

Primary Outcome Measures:
  • Target vessel failure (TVF) [ Time Frame: 270 days ] [ Designated as safety issue: Yes ]

Enrollment: 278
Study Start Date: April 2009
Study Completion Date: June 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Presillion™ Stent System Device: Catheterization, stent deployment
Standard catheterization procedure including Bare Metal Stent deployment.
Other Names:
  • CoCr Coronary Stent
  • Coronary Stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840775

Locations
Belgium
ZNA Middelheim
Antwerpen, Belgium, 2020
UZ Brussel
Brussels, Belgium, 1090
CHU Charleroi
Charleroi, Belgium, 6000
CHU de Liege
Liege, Belgium, 4000
Germany
Herz-Kreislauf-Zentrum Segeberger Kliniken
Bad Segeberg, Germany, D-23795
Charité - Campus Benjamin Franklin
Berlin, Germany, 12203
CardioVascular Center Frankfurt Sankt Katharinen
Frankfurt, Germany, 60389
University Hospital of Heidelberg
Heidelberg, Germany, 69120
Helios Klinkum
Siegburg, Germany, 53721
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Germany, D 78050
Israel
EMEK Medical Center
Afula, Israel, 18101
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sanz Medical Center, Laniado Hospital
Netanya, Israel, 42150
Assaf Harofeh Medical Center
Zerifin, Israel, 70300
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Lund University Hospital
Lund, Sweden
Sponsors and Collaborators
Medinol Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Michal Hershkowitz / VP of Clinical & Regulatory Affairs, Medinol Ltd.
ClinicalTrials.gov Identifier: NCT00840775     History of Changes
Other Study ID Numbers: CV103-01
Study First Received: February 9, 2009
Last Updated: August 11, 2011
Health Authority: Israel: Ethics Commission
Germany: Ethics Commission

Keywords provided by Medinol Ltd.:
Stent
interventional cardiology
catheterization
symptomatic ischemic heart disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014