Ischemic Heart DiseasePhase 4NCT00840775
PIONIR Study (Presillion™ and Presillion™ Plus Stent Systems)
A Phase 4 study testing Catheterization, stent deployment in people with Ischemic Heart Disease, run by Medinol Ltd. at 16 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Catheterization, stent deployment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Apr 2009to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Germany6 sites
Herz-Kreislauf-Zentrum Segeberger Kliniken
Bad Segeberg, D-23795
Charité - Campus Benjamin Franklin
Berlin, 12203
CardioVascular Center Frankfurt Sankt Katharinen
Frankfurt, 60389
University Hospital of Heidelberg
Heidelberg, 69120
Helios Klinkum
Siegburg, 53721
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, D 78050
Belgium4 sites
ZNA Middelheim
Antwerp, 2020
UZ Brussel
Brussels, 1090
CHU Charleroi
Charleroi, 6000
CHU de Liege
Liège, 4000
Israel4 sites
EMEK Medical Center
Afula, 18101
Hadassah Medical Organization
Jerusalem, 91120
Sanz Medical Center, Laniado Hospital
Netanya, 42150
Assaf Harofeh Medical Center
Tsrifin, 70300
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg
Lund University Hospital
Lund
About this study
Official title: Clinical Protocol Presillion™ and Presillion™ Plus Stent Systems
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.
Read the 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- Catheterization, stent deployment
- Keywords
- Stent, interventional cardiology, catheterization, symptomatic ischemic heart disease
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheterization, stent deploymentDevice
Also called CoCr Coronary Stent, Coronary Stent
Standard catheterization procedure including Bare Metal Stent deployment.
| Study group | Role | What they receive |
|---|---|---|
| Presillion™ Stent System | Other | Not described Receives: Device: Catheterization, stent deployment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel failure (TVF)
Measured: 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medinol Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840775
- Sponsor's protocol ID
- CV103-01
- Status last verified
- Mar 2018
- First submitted
- 9 Feb 2009
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Protocol Presillion™ and Presillion™ Plus Stent Systems
- ClinicalTrials.gov ID
- NCT00840775
- Acronym / sponsor ID
- CV103-01
- Conditions
- Ischemic Heart Disease
- Keywords
- Stent, interventional cardiology, catheterization, symptomatic ischemic heart disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Medinol Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Presillion™ Stent System | Other | Device: Catheterization, stent deployment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheterization, stent deploymentAlso: CoCr Coronary Stent, Coronary StentStandard catheterization procedure including Bare Metal Stent deployment. | Device | Presillion™ Stent System |
Primary outcome
Target vessel failure (TVF)
Time frame: 270 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Catheterization, stent deployment in people with Ischemic Heart Disease, run by Medinol Ltd. at 16 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Belgium, Israel, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel failure (TVF) (time frame: 270 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018; AzTrials last refreshed its copy on 3 Nov 2026.