NCT00840775

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2009

Typical duration for phase_4

Geographic Reach
4 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

February 9, 2009

Last Update Submit

March 25, 2018

Conditions

Ischemic Heart Disease

Keywords

Stentinterventional cardiologycatheterizationsymptomatic ischemic heart disease

Outcome Measures

Primary Outcomes (1)

  • Target vessel failure (TVF)

    270 days

Study Arms (1)

Presillion™ Stent System

OTHER
Device: Catheterization, stent deployment

Interventions

Catheterization, stent deploymentDEVICE

Standard catheterization procedure including Bare Metal Stent deployment.

Also known as: CoCr Coronary Stent, Coronary Stent
Presillion™ Stent System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

ZNA Middelheim

Antwerp, 2020, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

CHU Charleroi

Charleroi, 6000, Belgium

Location

CHU de Liege

Liège, 4000, Belgium

Location

Herz-Kreislauf-Zentrum Segeberger Kliniken

Bad Segeberg, D-23795, Germany

Location

Charité - Campus Benjamin Franklin

Berlin, 12203, Germany

Location

CardioVascular Center Frankfurt Sankt Katharinen

Frankfurt, 60389, Germany

Location

University Hospital of Heidelberg

Heidelberg, 69120, Germany

Location

Helios Klinkum

Siegburg, 53721, Germany

Location

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, D 78050, Germany

Location

EMEK Medical Center

Afula, 18101, Israel

Location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Sanz Medical Center, Laniado Hospital

Netanya, 42150, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Lund University Hospital

Lund, Sweden

Location

Related Links

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Catheterization

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 10, 2009

Study Start

April 1, 2009

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations

SE(2)DE(6)BE(4)IL(4)