Coronary Artery DiseasePhase 4OISTERNCT00914420
Optical Coherence Tomography (OCT) Evaluation of Re-endothelization: A Comparison of the Intrepide™ Stent Versus Taxus™
A Phase 4 study testing Intrepide Trapidil eluting stent and Taxus drug eluting stent in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Clearstream Technologies Ltd. at 1 site in Italy.
Trial summary
Patients presenting with ACS (Acute Coronary Syndrome) in the emergency department will be screened for clinical eligibility and asked to sign informed consent to the study. A total of 40 patients will be randomized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- Intrepide Trapidil eluting stent and Taxus drug eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2009to Oct 2012
- 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
- Clinical
- >18 years of age,
- symptoms of non ST-elevation ACS (defined by the ACC/AHA criteria) for 30 min but <48 h
- Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board
- Angiographic
- reference vessel diameter of culprit/target lesion between 2.25 to 3.5 mm (visual estimate)
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- discrete target lesion (maximum length of 28 mm by visual estimation)
- target lesion is in a native coronary artery
- presence of another lesion more than 70% in a vessel different from the culprit one amenable of planned percutaneous treatment 90 days thereafter.
Who cannot join
- Clinical
- previously documented left ventricular ejection fraction of less than 30%
- estimated life expectancy of less than 12 months
- a history of bleeding diathesis, leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction
- participation in another study
- inability to give informed consent owing to prolonged cardiopulmonary resuscitation
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- and dominant Renal impairment (serum creatinine > 2.0 mg/dl) Angiographic
- non-culprit lesion located in the proximal LAD or in a proximal and dominant Circumflex artery
- previous PCI of the target vessels restenosis or stent thrombosis as culprit lesion
- unprotected left main coronary artery disease
- non-culprit lesion located in a vein graft
- severe multivessel disease (three major epicardial vessel disease) need of overlapping stenting for one lesion
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Hospital Modena
Modena
Giuseppe M Sangiorgi, MD, sangiorgi.giuseppe@policlinico.mo.it
Giuseppe Sangiorgi, MD
About this study
Official title: OCT Evaluation of Stent Struts Re-endothelization in Patients With Acute Coronary Syndromes: a Comparison of the Intrepide™ Stent vs. Taxus™
Patients presenting with ACS (Acute Coronary Syndrome) in the emergency department will be screened for clinical eligibility and asked to sign informed consent to the study.
A total of 40 patients will be randomized. 20 of them will receive a Trapidil eluting stent (Intrepide™ stent), 20 will receive a Paclitaxel eluting stent (Taxus™ stent). After 90 days the patients who were treated with the INTREPIDE stent in the first lesion will be treated with the Taxus stent in the second lesion. After 90 days the patients who were treated with the Taxus stent in the first lesion will be treated with the INTREPIDE stent in the second lesion.
Coronary angiography will be performed through the femoral (groin) or radial (wrist) artery with the use of standard techniques. The doctor will determine if the patient is qualified for enrolment at the end of the diagnostic coronary angiogram
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Being tested
- Intrepide Trapidil eluting stent, Taxus drug eluting stent
- Keywords
- OCT, Reendothelialisation, Intrepide, Trapidil, Taxus
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrepide Trapidil eluting stentDevice
The INTREPIDE coronary stent system consists of a balloon expandable stent coated with two layers of Trapidil and parylene. The Trapidil eluting stent is pre-mounted on a Nimbus PCTA balloon and is intended for use in the treatment of CAD.
The controlled release of Trapidil is achieved through the parylene barrier, locally delivering the drug to the target lesion, inhibiting smooth muscle cell proliferation and hence neointimal hyperplasia.
Taxus drug eluting stentDevice
Paclitaxel Drug eluting stent manufactured by Boston Scientific
| Study group | Role | What they receive |
|---|---|---|
| Intrepide | Experimental | Group A- Primary stenting with Intrepide trapidil eluting stent Receives: Device: Intrepide Trapidil eluting stent |
| Taxus | Experimental | Group B Stenting with Taxus DES Receives: Device: Taxus drug eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare stent re-endothelialization using Trapidil drug eluting stent versus Taxus paclitaxel eluting stent at 3 months after intervention. The primary endpoint will be defined by % of stent struts neointimal coverage at 90 days
Measured: 3 months
Secondary outcomes (1)
In-stent binary angiographic restenosis and in-stent late lumen loss; in segment late loss; assessed by quantitative computed angiography (QCA) at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2010 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clearstream Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Antonio Columbo, MD, Principal investigator, San Raffaele hospital, MilanoGiuseppe M Sangiorgi, MD, Principal investigator, University Hospital Modena Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914420
- Sponsor's protocol ID
- CST10
- Acronym
- OISTER
- Status last verified
- Apr 2010
- First submitted
- 3 Jun 2009
- Last updated
- 19 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT Evaluation of Stent Struts Re-endothelization in Patients With Acute Coronary Syndromes: a Comparison of the Intrepide™ Stent vs. Taxus™
- ClinicalTrials.gov ID
- NCT00914420
- Acronym / sponsor ID
- OISTER / CST10
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Keywords
- OCT, Reendothelialisation, Intrepide, Trapidil, Taxus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clearstream Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 5 Jun 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.
Patients presenting with ACS (Acute Coronary Syndrome) in the emergency department will be screened for clinical eligibility and asked to sign informed consent to the study.
A total of 40 patients will be randomized. 20 of them will receive a Trapidil eluting stent (Intrepide™ stent), 20 will receive a Paclitaxel eluting stent (Taxus™ stent). After 90 days the patients who were treated with the INTREPIDE stent in the first lesion will be treated with the Taxus stent in the second lesion. After 90 days the patients who were treated with the Taxus stent in the first lesion will be treated with the INTREPIDE stent in the second lesion.
Coronary angiography will be performed through the femoral (groin) or radial (wrist) artery with the use of standard techniques. The doctor will determine if the patient is qualified for enrolment at the end of the diagnostic coronary angiogram
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrepide | Experimental | Device: Intrepide Trapidil eluting stentGroup A- Primary stenting with Intrepide trapidil eluting stent |
| Taxus | Experimental | Device: Taxus drug eluting stentGroup B Stenting with Taxus DES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical
- >18 years of age,
- symptoms of non ST-elevation ACS (defined by the ACC/AHA criteria) for 30 min but <48 h
- Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board
- Angiographic
Key exclusion criteria (12 listed)
- Clinical
- previously documented left ventricular ejection fraction of less than 30%
- estimated life expectancy of less than 12 months
- a history of bleeding diathesis, leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction
- participation in another study
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 |
|---|---|---|
| Intrepide Trapidil eluting stentThe INTREPIDE coronary stent system consists of a balloon expandable stent coated with two layers of Trapidil and parylene. The Trapidil eluting stent is pre-mounted on a Nimbus PCTA balloon and is intended for use in the treatment of CAD. The controlled release of Trapidil is achieved through the parylene barrier, locally delivering the drug to the target lesion, inhibiting smooth muscle cell proliferation and hence neointimal hyperplasia. | Device | Intrepide |
| Taxus drug eluting stentPaclitaxel Drug eluting stent manufactured by Boston Scientific | Device | Taxus |
Primary outcome
To compare stent re-endothelialization using Trapidil drug eluting stent versus Taxus paclitaxel eluting stent at 3 months after intervention. The primary endpoint will be defined by % of stent struts neointimal coverage at 90 days
Time frame: 3 months
1 secondary outcome
In-stent binary angiographic restenosis and in-stent late lumen loss; in segment late loss; assessed by quantitative computed angiography (QCA) at 12 months
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 19 Apr 2010.
- Industry SponsorLink 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.
Antonio Columbo, MD principal investigator
San Raffaele hospital, Milano
Giuseppe M Sangiorgi, MD principal investigator
University Hospital Modena Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrepide Trapidil eluting stent and Taxus drug eluting stent in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Clearstream Technologies Ltd. at 1 site in Italy.
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 9 inclusion and 12 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 19 Apr 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare stent re-endothelialization using Trapidil drug eluting stent versus Taxus paclitaxel eluting stent at 3 months after intervention. The primary endpoint will be defined by % of stent struts neointimal coverage at 90 days (time frame: 3 months). 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 19 Apr 2010.