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

Ischemic Heart Disease Clinical Trial

Official title:

Clinical Protocol Presillion™ and Presillion™ Plus Stent Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840775
• Other study ID #: CV103-01
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2009
• Last updated: March 25, 2018
• Start date: April 2009
• Est. completion date: June 2011

Study information

• Verified date: March 2018
• Source: Medinol Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Catheterization, stent deployment
Standard catheterization procedure including Bare Metal Stent deployment.

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerpen
Belgium	UZ Brussel	Brussels
Belgium	CHU Charleroi	Charleroi
Belgium	CHU de Liege	Liege
Germany	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
Israel	EMEK Medical Center	Afula
Israel	Hadassah Medical Organization	Jerusalem
Israel	Sanz Medical Center, Laniado Hospital	Netanya
Israel	Assaf Harofeh Medical Center	Zerifin
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Lund University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Medinol Ltd.

Countries where clinical trial is conducted

Belgium,  Germany,  Israel,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target vessel failure (TVF)		270 days

External Links

•   Link