Clinical trial NCT00840775: PIONIR Study (Presillion™ and Presillion™ Plus Stent Systems)
Official title: Clinical Protocol Presillion™ and Presillion™ Plus Stent Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Heart Disease
Keywords: Stent
interventional cardiology
catheterization
symptomatic ischemic heart disease
Lead sponsor: Medinol Ltd.
Sponsor class: INDUSTRY
First posted: 2009-02-10
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 coronary arteries.

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 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.

Primary outcomes:
measure: Target vessel failure (TVF)
timeFrame: 270 days
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brussels
country: Belgium
facility: UZ Brussel
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Liege
country: Belgium
facility: CHU de Liege
city: Bad Segeberg
country: Germany
facility: Herz-Kreislauf-Zentrum Segeberger Kliniken
city: Berlin
country: Germany
facility: Charité - Campus Benjamin Franklin
city: Frankfurt
country: Germany
facility: CardioVascular Center Frankfurt Sankt Katharinen
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg
city: Siegburg
country: Germany
facility: Helios Klinkum
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
city: Afula
country: Israel
facility: EMEK Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Netanya
country: Israel
facility: Sanz Medical Center, Laniado Hospital
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: Lund University Hospital
Study officials:
References: