Status:
COMPLETED
PIONIR Study (Presillion™ and Presillion™ Plus Stent Systems)
Lead Sponsor:
Medinol Ltd.
Conditions:
Ischemic Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 cor...
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 m...
Eligibility Criteria
Inclusion
- Patient \>= 18 years old.
- Eligible for Percutaneous Coronary Intervention (PCI).
- Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
- Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
- Acceptable candidate for coronary artery bypass graft (CABG) surgery.
- 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).
- 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
- 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.
- Previously enrolled in another stent trial in the previous 2 years.
- ANY planned elective surgery or percutaneous intervention within subsequent 9 months.
- A previous coronary interventional procedure of any kind within the 30 days prior to the procedure.
- The subject requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
- Previous drug eluting stent (DES) deployment anywhere in the target vessel.
- Any drug eluting stent (DES) deployment anywhere within the past 12 months
- 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.
- Concurrent medical condition with a life expectancy of less than 12 months.
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT00840775
Start Date
April 1 2009
End Date
June 1 2011
Last Update
March 27 2018
Active Locations (16)
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1
ZNA Middelheim
Antwerp, Belgium, 2020
2
UZ Brussel
Brussels, Belgium, 1090
3
CHU Charleroi
Charleroi, Belgium, 6000
4
CHU de Liege
Liège, Belgium, 4000