HyperplasiaPhase 2/3NAUTICNCT00774917

Numen Stent Assessment Using OCT Technique in a Single Center Study

A Phase 2/3 study testing Numen in people with Hyperplasia and Restenosis, run by International Biomedical Systems S.p.A. at 2 sites in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a prospective single centre Study designed to assess by OCT the effect of NUMEN cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or ACS (except STEMI). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyperplasia, Restenosis
What is being tested?: Numen
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesAustria
Study dates: Oct 2008to Mar 2010
Phase: Phase 2/3
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

Patients must meet all of the following criteria:
The patient must be > 18 years of age;
Diagnosis of stable angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) or ACS (except STEMI).
Treatment of de novo lesion in a major coronary artery in patients with single or two-vessel disease.
Target vessel diameter at the lesion site is >2.50mm and <3.50mm in diameter (QCA);
Target lesion is >10mm and <24mm in length (visual estimate);

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Target lesion stenosis is >50% and <100% (visual estimate);
Acceptable candidate for coronary artery bypass surgery (CABG);
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

Patients will be excluded if any of the following conditions apply:
multiple lesions in the same vessel;
ACS with STEMI (within 48 hours)
vessel size < 2.50mm and >3.50mm reference diameter;
length of the lesion > 24 mm;
unprotected left main coronary disease with >50% stenosis;

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have an ostial target lesion;
have a target lesion in a venous graft;
angiographic evidence of thrombus within target lesion;
calcified lesion which cannot be successfully predilated;
Documented left ventricular ejection fraction >25%;
Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Pretreatment with devices other than balloon angioplasty;
Prior stent within 5mm of target lesion;
Recipient of heart transplant;
Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, cobalt, chromium, or contrast agent (that cannot be managed medically)
Recent (6 months) cerebrovascular accidents or intracranial hemorrage
Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
Currently participating in an investigational drug or another medical device study;
In the investigator's opinion, the lesion is not suitable for stenting.
Life expectancy ≤ 12 months

Trial locations and contacts

2 sites in 1 country.

Helmut-Dietmar Glogar, Professor contact

01/40400-4614

Mariann Pavone Gyongyosi, Doz. Dr. contact

01/40400-4614

Austria2 sites, 1 recruiting

SMZ-Ost Donauspital
Vienna
Active, not recruiting
University Hospital of Vienna
Vienna (Austria), State of Vienna
Marianne Pavone-Gyongyosi, Doz.Dr, 01/40400-4614
Recruiting

Other trials in Austria

About this study

A total of 60 consecutive patients will be enrolled in the study. Patients with de novo native coronary artery lesions >10mm and <24mm in length and >2.50mm to <3.50mm in diameter by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent implantation. After stent deployment an OCT imaging will be performed within the treated segment. Patients will be followed at 30 days, 6 months and 12 months post-procedure, with all patients having repeat angiography and OCT at 6 months.

It is anticipated that the total length of the study will be 18 months: 6 months to complete patient enrolment and 12 months for follow-up.

Read the detailed description

OBJECTIVES

The main objective of this study is to assess the long term influence of NUMEN cobalt-chromium balloon-expandable coronary stent on neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or Acute Coronary Syndrom (ACS) - except STEMI.

ENDPOINTS

The primary endpoint is the assessment of the development of neointimal hyperplasia by OCT in the stented segment at 6-month follow-up.

Breakdown of secondary endpoints:

Degree of endothelialization of the stent internal wall by OCT at 6 months after stent implantation; Composite of Major Adverse Cardiac Events (MACE) defined as cardiac death, non-fatal myocardial infarction (MI) (Q wave and non-Q wave), emergent bypass surgery, stent thrombosis, or repeat target lesion revascularization at 30 days, 6 months and 12 months post-procedure.

Angiographic binary restenosis (>50% diameter stenosis) 6 months post-procedure.

Target vessel failure at 6 months post-procedure. Device success defined as achievement of a final residual diameter stenosis of <30% (by Quantitative Coronary Angiography (QCA)), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.

Lesion success defined as the attainment of <30% residual stenosis (by QCA) using any percutaneous method.

Procedure success defined as achievement of a final diameter stenosis of <30% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay.

Acute (24 hrs post procedure), subacute (up to 30days post procedure) and late (>30days post procedure) thrombosis.

OVERVIEW OF THE STUDY

A total of 60 consecutive patients will be enrolled in the study. Patients with de novo native coronary artery lesions >10mm and < 24mm in length and >2.50mm to <3.50mm in diameter by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent implantation. After stent deployment an OCT imaging will be performed within the treated segment. Patients will be followed at 30 days, 6 months and 12 months post-procedure, with all patients having repeat angiography and OCT at 6 months.

It is anticipated that the total length of the study will be 18 months: 6 months to complete patient enrolment and 12 months for follow-up.

Conditions: Hyperplasia, Restenosis
Being tested: Numen
Keywords: numen, hyperplasia
Medical subject headings: Hyperplasia

What participants receive

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

NumenDevice
Numen Co-Cr coronary stent implant

Study groups in NCT00774917
Study group	Role	What they receive
Numen	Experimental	Not described Receives: Device: Numen

What is being measured

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

The primary endpoint is the assessment of the development of neointimal hyperplasia by OCT in the stented segment at 6-month follow-up.
Measured: 6 months

Secondary outcomes (1)

Endothelialization of the stent internal wall by OCT at 6 months ; (MACE) at 30 days, 6 and 12 months Angiographic binary restenosis at 6m Target vessel failure at 6m. Device, lesion, procedure success. Thrombosis
Measured: 12 months

Timeline

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

Oct 2008Mar 2010

First posted17 Oct 2008 (estimated)
Study startOct 2008
Primary completionSep 2009 (estimated)
Study completionMar 2010 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HyperplasiaStudies 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 2/3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00774917
Sponsor's protocol ID: CSC-IBS/05-2007
Acronym: NAUTIC
Status last verified: Jun 2009
First submitted: 16 Oct 2008
Last updated: 23 Jun 2009
Results posted: No
Data monitoring committee: No

Want to know more?

Helmut-Dietmar Glogar, Professor

01/40400-4614

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Numen Stent Assessment Using OCT Technique in a Single Center Study
ClinicalTrials.gov ID: NCT00774917
Acronym / sponsor ID: NAUTIC / CSC-IBS/05-2007
Conditions: Hyperplasia, Restenosis
Keywords: numen, hyperplasia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: International Biomedical Systems S.p.A.Industry (pharma, biotech, devices)
Collaborators: CSC Pharmaceuticals
Study start: Oct 2008
Primary completion: Sep 2009 (estimated)
Study completion: Mar 2010 (estimated)
First posted: 17 Oct 2008 (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.

It is anticipated that the total length of the study will be 18 months: 6 months to complete patient enrolment and 12 months for follow-up.

Detailed description

OBJECTIVES

ENDPOINTS

The primary endpoint is the assessment of the development of neointimal hyperplasia by OCT in the stented segment at 6-month follow-up.

Breakdown of secondary endpoints:

Angiographic binary restenosis (>50% diameter stenosis) 6 months post-procedure.

Lesion success defined as the attainment of <30% residual stenosis (by QCA) using any percutaneous method.

Acute (24 hrs post procedure), subacute (up to 30days post procedure) and late (>30days post procedure) thrombosis.

OVERVIEW OF THE STUDY

A total of 60 consecutive patients will be enrolled in the study. Patients with de novo native coronary artery lesions >10mm and < 24mm in length and >2.50mm to <3.50mm in diameter by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent implantation. After stent deployment an OCT imaging will be performed within the treated segment. Patients will be followed at 30 days, 6 months and 12 months post-procedure, with all patients having repeat angiography and OCT at 6 months.

It is anticipated that the total length of the study will be 18 months: 6 months to complete patient enrolment and 12 months for follow-up.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Numen	Experimental	Device: Numen

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

The patient must be > 18 years of age;
Diagnosis of stable angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) or ACS (except STEMI).
Treatment of de novo lesion in a major coronary artery in patients with single or two-vessel disease.
Target vessel diameter at the lesion site is >2.50mm and <3.50mm in diameter (QCA);
Target lesion is >10mm and <24mm in length (visual estimate);

Key exclusion criteria (21 listed)

multiple lesions in the same vessel;
ACS with STEMI (within 48 hours)
vessel size < 2.50mm and >3.50mm reference diameter;
length of the lesion > 24 mm;
unprotected left main coronary disease with >50% stenosis;

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
NumenNumen Co-Cr coronary stent implant	Device	Numen

Primary outcome

The primary endpoint is the assessment of the development of neointimal hyperplasia by OCT in the stented segment at 6-month follow-up.
Time frame: 6 months

1 secondary outcome

Endothelialization of the stent internal wall by OCT at 6 months ; (MACE) at 30 days, 6 and 12 months Angiographic binary restenosis at 6m Target vessel failure at 6m. Device, lesion, procedure success. Thrombosis
Time frame: 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2009.

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RecruitingPhase 2
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Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
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Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
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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.

Helmut-Dietmar Glogar, Professor contact

01/40400-4614

Mariann Pavone Gyongyosi, Doz. Dr. contact

01/40400-4614

Helmut Dietmar Glogar, Prof. principal investigator

University Hospital of Vienna

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Numen in people with Hyperplasia and Restenosis, run by International Biomedical Systems S.p.A. at 2 sites in Austria.

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 10 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 23 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Helmut-Dietmar Glogar, Professor (01/40400-4614), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint is the assessment of the development of neointimal hyperplasia by OCT in the stented segment at 6-month follow-up. (time frame: 6 months). 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 NCT00774917.

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 23 Jun 2009.