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Coronary Artery DiseasePhase 3PRESILLIONNCT00722579

A Study of the Presillion Stent in de Novo Coronary Lesions

A Phase 3 study testing PRESILLION cobalt chromium stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The PRESILLION Study is a non-randomized, multi-center, single-arm study evaluating the safety of an approved Cobalt Chromium bare metal stent system for the treatment of ischemic heart disease attributable to a stenotic de novo lesion in a native coronary artery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
PRESILLION cobalt chromium stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteBelgium
Study dates
Jul 2008to Mar 2010
Phase
Phase 3
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

  • The patient must be >= 18 years of age.
  • Patient is eligible for percutaneous coronary intervention (PCI).
  • Acceptable candidate for coronary artery bypass surgery (CABG).
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment and utilize reliable birth control for trial duration.
  • Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) or unstable angina pectoris (Braunwald Classification B\&C, I-II-III) or patients with documented silent ischemia.
  • Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries.
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  • Target reference vessel diameter of both lesions must be >= 2.5mm and <= 4.0mm in diameter (visual estimate).
  • Target lesion length must be <= 30mm and be covered by one study stent.
  • Target lesion stenosis for both lesions is > 50% and < 100% (visual estimate).
  • At least TIMI I coronary flow.
  • Patient is willing to comply with the specified follow-up evaluation.
  • Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee.

Who cannot join

  • Recent myocardial infarction (either STEMI or non STEMI < 48 hours prior to planned index procedure).
  • The patient has unstable angina classified as Braunwald A I-II-III.
  • The patient has unprotected left main coronary artery disease (stenosis >50%).
  • A significant (> 50%) stenosis proximal or distal to the target lesion.
  • Angiographic evidence of thrombus within the target lesion.
  • Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated and/or an excessively tortuous vessel which makes it unsuitable for stent delivery and deployment.
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  • Left ventricular ejection fraction <= 25%.
  • Totally occluded lesion (TIMI 0 level).
  • The patient has impaired renal function (creatinine 3.0mg/dL) at the time of treatment.
  • The patient had a Cerebrovascular Accident (CVA) within the past 6 months.
  • Prior stent within 10mm of target lesion.
  • The target lesion is ostial in location (within 3.0mm of vessel origin).
  • The target lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >= 2.0mm in diameter (or side branch requiring intervention of protection).
  • The target lesion is located in a bypass graft. Note: stenting of lesions in bypassed native coronary arteries is allowed.
  • Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix ®) and ticlopidine (Ticlid ®), heparin, cobalt chromium, contrast agent (that cannot be managed medically).
  • The patient has any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
  • The patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
  • Intervention of another lesion within 30 days prior to, or is planned or highly probably to be performed 30 days after the index procedure.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • CHU de Liège

    Liège, B-4000

Other trials in Belgium

About this study

Official title: A Non-Randomized, Multi-Center, Single-Arm Safety Study of the Presillion Stent in de Novo Native Coronary Artery Lesions

The PRESILLION Study is a non-randomized, multi-center, single-arm study evaluating the safety of an approved Cobalt Chromium bare metal stent system for the treatment of ischemic heart disease attributable to a stenotic de novo lesion in a native coronary artery.

The study population will include 100 patients with up to two de novo native coronary artery lesions with a maximum lesion length of 30mm in a maximum of two major coronary arteries with reference vessel diameter >= 2.5mm and <= 4.0mm by visual estimation. Patients will be followed for 1 month and 6 month post-procedure for assessment of MACE and all other adverse events.

Read the detailed description

The PRESILLION Stent System is intended for use in patients with symptomatic ischemic heart disease attributable to stenotic de novo lesions of native coronary arteries with reference vessel diameter from 2.5 mm to 4.0 mm with a lesion length up to 30 mm that are amenable to percutaneous treatment with coronary stenting. The stent is intended as a permanent implanted device.

The primary objective of this study is to evaluate the safety of the PRESILLION Stent System in the treatment of de novo stenotic lesions in native coronary arteries. The primary safety measure is the composite of MACE up to one (1) month follow up. The MACE rate shall meet the performance goal for bare metal stents in order to show the safety of the device.

The protocol has been amended and data will be collected for a time point as close as possible to (but after) the 6 months post index procedure in a non-interventional and retrospective manner. The data point will contain exactly the same follow-up information as was collected during the 1 month follow-up.

Being tested
PRESILLION cobalt chromium stent
Keywords
Coronary Artery Disease
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRESILLION cobalt chromium stentDevice

    Also called bare-metal stent

    PTCA with bare-metal stent

Study groups in NCT00722579
Study groupRoleWhat they receive
AExperimentalThe PRESILLION TM Coronary Stent is an L-605 cobalt chromium (CoCr) stent.
Receives: Device: PRESILLION cobalt chromium stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of MACE which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR).

    Measured: 1-month and 6-months post-procedure

Secondary outcomes (10)

  1. Clinically driven Target Lesion Revascularization (TLR) defined as repeat PCI or CABG to the target lesion.

    Measured: 1-month and 6-months post-procedure

  2. Clinically driven Target Vessel Revascularization (TVR) defined as repeat PCI or CABG to the target vessel.

    Measured: 1-month and 6-months post-procedure

  3. Target Vessel Failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.

    Measured: 1-month and 6-months post-procedure

  4. Myocardial Infarction (MI).

    Measured: 1-month and 6-months post-procedure

  5. Major bleeding.

    Measured: 1-month and 6-months post-procedure

  6. Device success.

    Measured: Post-procedure

  7. Lesion success.

    Measured: Post-procedure

  8. Procedure success.

    Measured: Post-procedure

  9. Incidence of acute and sub-acute stent thrombosis according the ARC definition.

    Measured: 1-month and 6-months post-procedure

  10. Stroke.

    Measured: Post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2008
  4. Study completionMar 2010

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00722579
Sponsor's protocol ID
EC08-01
Acronym
PRESILLION
Status last verified
Jun 2010
First submitted
24 Jul 2008
Last updated
14 Jun 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PRESILLION cobalt chromium stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Belgium.

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 12 inclusion and 18 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 14 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Composite of MACE which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR). (time frame: 1-month and 6-months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00722579.

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 14 Jun 2010.

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