Optical Coherence Tomography (OCT) Evaluation of Re-endothelization: A Comparison of the Intrepide™ Stent Versus Taxus™ (OISTER)
Primary Purpose
Coronary Artery Disease, Acute Coronary Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Intrepide Trapidil eluting stent
Taxus drug eluting stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring OCT, Reendothelialisation, Intrepide, Trapidil, Taxus
Eligibility Criteria
Inclusion Criteria:
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)
- 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.
Exclusion Criteria:
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
- 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
Sites / Locations
- University Hospital ModenaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intrepide
Taxus
Arm Description
Group A- Primary stenting with Intrepide trapidil eluting stent
Group B Stenting with Taxus DES
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
In-stent binary angiographic restenosis and in-stent late lumen loss; in segment late loss; assessed by quantitative computed angiography (QCA) at 12 months
Full Information
NCT ID
NCT00914420
First Posted
June 3, 2009
Last Updated
April 16, 2010
Sponsor
Clearstream Technologies Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00914420
Brief Title
Optical Coherence Tomography (OCT) Evaluation of Re-endothelization: A Comparison of the Intrepide™ Stent Versus Taxus™
Acronym
OISTER
Official Title
OCT Evaluation of Stent Struts Re-endothelization in Patients With Acute Coronary Syndromes: a Comparison of the Intrepide™ Stent vs. Taxus™
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Clearstream Technologies Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Acute Coronary Syndrome
Keywords
OCT, Reendothelialisation, Intrepide, Trapidil, Taxus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intrepide
Arm Type
Experimental
Arm Description
Group A- Primary stenting with Intrepide trapidil eluting stent
Arm Title
Taxus
Arm Type
Experimental
Arm Description
Group B Stenting with Taxus DES
Intervention Type
Device
Intervention Name(s)
Intrepide Trapidil eluting stent
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Taxus drug eluting stent
Intervention Description
Paclitaxel Drug eluting stent manufactured by Boston Scientific
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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.
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Columbo, MD
Organizational Affiliation
San Raffaele hospital, Milano
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giuseppe M Sangiorgi, MD
Organizational Affiliation
University Hospital Modena Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Modena
City
Modena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe M Sangiorgi, MD
Email
sangiorgi.giuseppe@policlinico.mo.it
First Name & Middle Initial & Last Name & Degree
Giuseppe Sangiorgi, MD
12. IPD Sharing Statement
Links:
URL
http://www.clearstream.ie
Description
Industry Sponsor
Learn more about this trial
Optical Coherence Tomography (OCT) Evaluation of Re-endothelization: A Comparison of the Intrepide™ Stent Versus Taxus™
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