PIONIR Study (Presillion™ and Presillion™ Plus Stent Systems)
NCT ID: NCT00840775
Last Updated: 2018-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
278 participants
INTERVENTIONAL
2009-04-30
2011-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Presillion™ Stent System
Catheterization, stent deployment
Standard catheterization procedure including Bare Metal Stent deployment.
Interventions
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Catheterization, stent deployment
Standard catheterization procedure including Bare Metal Stent deployment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Medinol Ltd.
INDUSTRY
Responsible Party
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Locations
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ZNA Middelheim
Antwerp, , Belgium
UZ Brussel
Brussels, , Belgium
CHU Charleroi
Charleroi, , Belgium
CHU de Liege
Liège, , Belgium
Herz-Kreislauf-Zentrum Segeberger Kliniken
Bad Segeberg, , Germany
Charité - Campus Benjamin Franklin
Berlin, , Germany
CardioVascular Center Frankfurt Sankt Katharinen
Frankfurt, , Germany
University Hospital of Heidelberg
Heidelberg, , Germany
Helios Klinkum
Siegburg, , Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, , Germany
EMEK Medical Center
Afula, , Israel
Hadassah Medical Organization
Jerusalem, , Israel
Sanz Medical Center, Laniado Hospital
Netanya, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Sahlgrenska University Hospital
Gothenburg, , Sweden
Lund University Hospital
Lund, , Sweden
Countries
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Related Links
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Related Info
Other Identifiers
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CV103-01
Identifier Type: -
Identifier Source: org_study_id
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