Coronary Artery DiseasePhase 4ODESSANCT00693030
Optical Coherence Tomography for Drug Eluting Stent Safety
A Phase 4 study testing sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co), paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS) and zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA) in people with Coronary Artery Disease, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
Trial summary
Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the use of overlapping drug-eluting stents. Whether the substantial impairment of arterial healing observed at sites of overlap in preclinical pathologic studies persists in patients undergoing PCI is unknown. 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?
- sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co), paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS) and zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2006to Dec 2008
- 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
- Native coronary artery disease with ≥ 75% diameter stenosis
- Lesion length ≥ 20 mm,
- Vessel size in between 2.5 and 3.5 mm.
- Multiple, overlapped DES vs BMS placement (intention to overlap ≥ 4 mm)
- Signed patient informed consent
Who cannot join
- left main coronary artery disease,
- lesions in coronary artery bypass grafts,
- acute myocardial infarction,
- poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%.
- allergy to aspirin and or clopidogrel/ticlo,
- renal failure with creatinine value > 2.5,
- no suitable anatomy for OCT scan
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Cardiovascular Department Ospedali Riuniti di Bergamo
Bergamo, 24100
Giulio Guagliumi, MD, 39-03-526-6455, guagliumig@interfree.it
Giuseppe Musumeci, MD, 39-03-526-6455, giuseppe.musumeci@gmail.it
About this study
Official title: In-Vivo Vascular Response of Sirolimus-,Paclitaxel- and Zotarolimus-Eluting Stents in Long Lesions Requiring Overlapping. A Prospective, Randomized, Controlled Study Using Optical Coherence Tomography
Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the use of overlapping drug-eluting stents. Whether the substantial impairment of arterial healing observed at sites of overlap in preclinical pathologic studies persists in patients undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels requiring stents in overlap are prospectively randomized to receive multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents versus bare metal stents. The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up
Read the detailed description
If overlapping drug-eluting stents provide increased vessel toxicity is not known. Given the association of delayed healing and incomplete endothelialization observed in animal and human autopsy studies at overlapping sites it is unclear why most patients do well with multiple DES implanted. OCT detecs smaller degrees of in-stent neointima more accurately than IVUS and might be a useful method for identify strut coverage and/or malapposition.
Patients if eligible on the basis of clinical and angiographic criteria, are randomized (2:2:2:1) to receive multiple TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ vs Libertè BM stents, in overlap. Stent implantation are done accordingly to the normal interventional practice. QCA and IVUS are performed at the end of optimal stents placement per visual judgement (residual stenosis < 10%, TIMI 3 flow). Stent, lumen size and volume as well as complete stent strut apposal will be determined by IVUS analysis. Clinical follow-up will take place at 1 month (±1 week), 6 months (±2 weeks) and 1 year (±2 weeks). At 6-months follow-up all patients will undergo a quantitative coronary angiography (QCA), IVUS and Optical Coherence Tomography (LightLab OCT Imaging M2, automated pull back and flushing combination)assessments.
OCT images will be acquired at 15-30 frames per second. Blind corelab quantitative strut by strut analysis will be performed using a novel dedicated software at each 0.5 mm section. The following OCT variables will be evaluated:number of visualized strut per section, mean-max neointimal thickness per section, % struts well apposed with neointima at overlapping vs non overlapping sites, % struts without neointima, % struts malapposed, rate of > 30% uncovered struts/total number of struts per section.
- Conditions
- Coronary Artery Disease
- Being tested
- sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co), paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS), zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA), Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)
- Keywords
- Coronary Artery Disease, Percutaneous Coronary Interventions, Drug-Eluting stents, Optical Coherence Tomography, Thrombosis, Long lesions in native vessel requiring stents in overlap
- Medical subject headings
- Coronary Artery Disease, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)Device
Also called Cypher™ (Cordis Corp, Johnson & Johnson Co) DES
comparison of multiple drug eluting stents
paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)Device
Also called Taxus Libertè™ (Boston Scientific, Natick MS) DES
comparison of multiple drug eluting coronary stents
zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)Device
Also called Endeavor™ (Medtronic, Santa Rosa, CA) DES
comparison of multiple drug eluting coronary stents
Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)Device
Also called Libertè™ BMS(Boston Scientific, Natick, MS)
comparison of DES in overlap vs BMS in overlap
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Device, Sirolimus drug-eluting stents implanted in overlap Receives: Device: sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co) |
| 2 | Active comparator | Device, paclitaxel polymer drug eluting stent Receives: Device: paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS) |
| 3 | Active comparator | Device, zotarolimus drug eluting stent Receives: Device: zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA) |
| 4 | Active comparator | bare metal coronary stents Receives: Device: Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of uncovered and/or malapposed stent struts at overlapping versus non overlapping sites in drug eluting vs bare metal stents
Measured: 6 months
Secondary outcomes (2)
Ischemia Driven Target Vessel Failure
Measured: 12 months
Number of uncovered and/or malapposed stent struts at overlapping sites in sirolimus-, paclitaxel- or zotarolimus eluting stents
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startAug 2006
- Primary completionJun 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Medtronic Vascular, Boston Scientific Corporation
- Investigators
- Giulio Guagliumi, MD, Principal investigator, Cardiovascular Department Ospedali Riuniti di Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693030
- Sponsor's protocol ID
- 0106
- Acronym
- ODESSA
- Status last verified
- Jun 2008
- First submitted
- 4 Jun 2008
- Last updated
- 6 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.
PubMed 16814667Finn AV, Kolodgie FD, Harnek J, Guerrero LJ, Acampado E, Tefera K, Skorija K, Weber DK, Gold HK, Virmani R. Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents. Circulation. 2005 Jul 12;112(2):270-8. doi: 10.1161/CIRCULATIONAHA.104.508937. Epub 2005 Jul 5.
PubMed 15998681Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.
PubMed 17438147Finn AV, Nakazawa G, Joner M, Kolodgie FD, Mont EK, Gold HK, Virmani R. Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol. 2007 Jul;27(7):1500-10. doi: 10.1161/ATVBAHA.107.144220. Epub 2007 May 17.
PubMed 17510464Nakazawa G, Finn AV, John MC, Kolodgie FD, Virmani R. The significance of preclinical evaluation of sirolimus-, paclitaxel-, and zotarolimus-eluting stents. Am J Cardiol. 2007 Oct 22;100(8B):36M-44M. doi: 10.1016/j.amjcard.2007.08.020.
PubMed 17950831Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. doi: 10.1093/eurheartj/ehl413. Epub 2006 Nov 29.
PubMed 17135281Bouma BE, Tearney GJ, Yabushita H, Shishkov M, Kauffman CR, DeJoseph Gauthier D, MacNeill BD, Houser SL, Aretz HT, Halpern EF, Jang IK. Evaluation of intracoronary stenting by intravascular optical coherence tomography. Heart. 2003 Mar;89(3):317-20. doi: 10.1136/heart.89.3.317.
PubMed 12591841Takano M, Inami S, Jang IK, Yamamoto M, Murakami D, Seimiya K, Ohba T, Mizuno K. Evaluation by optical coherence tomography of neointimal coverage of sirolimus-eluting stent three months after implantation. Am J Cardiol. 2007 Apr 15;99(8):1033-8. doi: 10.1016/j.amjcard.2006.11.068. Epub 2007 Feb 23.
PubMed 17437723Yamaguchi T, Terashima M, Akasaka T, Hayashi T, Mizuno K, Muramatsu T, Nakamura M, Nakamura S, Saito S, Takano M, Takayama T, Yoshikawa J, Suzuki T. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical setting. Am J Cardiol. 2008 Mar 1;101(5):562-7. doi: 10.1016/j.amjcard.2007.09.116. Epub 2008 Jan 10.
PubMed 18307999Guagliumi G, Musumeci G, Sirbu V, Bezerra HG, Suzuki N, Fiocca L, Matiashvili A, Lortkipanidze N, Trivisonno A, Valsecchi O, Biondi-Zoccai G, Costa MA; ODESSA Trial Investigators. Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents. JACC Cardiovasc Interv. 2010 May;3(5):531-9. doi: 10.1016/j.jcin.2010.02.008.
PubMed 20488410
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Vivo Vascular Response of Sirolimus-,Paclitaxel- and Zotarolimus-Eluting Stents in Long Lesions Requiring Overlapping. A Prospective, Randomized, Controlled Study Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT00693030
- Acronym / sponsor ID
- ODESSA / 0106
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Percutaneous Coronary Interventions, Drug-Eluting stents, Optical Coherence Tomography, Thrombosis, Long lesions in native vessel requiring stents in overlap
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Medtronic Vascular, Boston Scientific Corporation
- Study start
- Aug 2006
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 6 Jun 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.
Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the use of overlapping drug-eluting stents. Whether the substantial impairment of arterial healing observed at sites of overlap in preclinical pathologic studies persists in patients undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels requiring stents in overlap are prospectively randomized to receive multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents versus bare metal stents. The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up
Detailed description
If overlapping drug-eluting stents provide increased vessel toxicity is not known. Given the association of delayed healing and incomplete endothelialization observed in animal and human autopsy studies at overlapping sites it is unclear why most patients do well with multiple DES implanted. OCT detecs smaller degrees of in-stent neointima more accurately than IVUS and might be a useful method for identify strut coverage and/or malapposition.
Patients if eligible on the basis of clinical and angiographic criteria, are randomized (2:2:2:1) to receive multiple TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ vs Libertè BM stents, in overlap. Stent implantation are done accordingly to the normal interventional practice. QCA and IVUS are performed at the end of optimal stents placement per visual judgement (residual stenosis < 10%, TIMI 3 flow). Stent, lumen size and volume as well as complete stent strut apposal will be determined by IVUS analysis. Clinical follow-up will take place at 1 month (±1 week), 6 months (±2 weeks) and 1 year (±2 weeks). At 6-months follow-up all patients will undergo a quantitative coronary angiography (QCA), IVUS and Optical Coherence Tomography (LightLab OCT Imaging M2, automated pull back and flushing combination)assessments.
OCT images will be acquired at 15-30 frames per second. Blind corelab quantitative strut by strut analysis will be performed using a novel dedicated software at each 0.5 mm section. The following OCT variables will be evaluated:number of visualized strut per section, mean-max neointimal thickness per section, % struts well apposed with neointima at overlapping vs non overlapping sites, % struts without neointima, % struts malapposed, rate of > 30% uncovered struts/total number of struts per section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)Device, Sirolimus drug-eluting stents implanted in overlap |
| 2 | Active comparator | Device: paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)Device, paclitaxel polymer drug eluting stent |
| 3 | Active comparator | Device: zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)Device, zotarolimus drug eluting stent |
| 4 | Active comparator | Device: Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)bare metal coronary stents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Native coronary artery disease with ≥ 75% diameter stenosis
- Lesion length ≥ 20 mm,
- Vessel size in between 2.5 and 3.5 mm.
- Multiple, overlapped DES vs BMS placement (intention to overlap ≥ 4 mm)
- Signed patient informed consent
Key exclusion criteria (7 listed)
- left main coronary artery disease,
- lesions in coronary artery bypass grafts,
- acute myocardial infarction,
- poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%.
- allergy to aspirin and or clopidogrel/ticlo,
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 |
|---|---|---|
| sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)Also: Cypher™ (Cordis Corp, Johnson & Johnson Co) DEScomparison of multiple drug eluting stents | Device | 1 |
| paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)Also: Taxus Libertè™ (Boston Scientific, Natick MS) DEScomparison of multiple drug eluting coronary stents | Device | 2 |
| zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)Also: Endeavor™ (Medtronic, Santa Rosa, CA) DEScomparison of multiple drug eluting coronary stents | Device | 3 |
| Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)Also: Libertè™ BMS(Boston Scientific, Natick, MS)comparison of DES in overlap vs BMS in overlap | Device | 4 |
Primary outcome
Number of uncovered and/or malapposed stent struts at overlapping versus non overlapping sites in drug eluting vs bare metal stents
Time frame: 6 months
2 secondary outcomes
Ischemia Driven Target Vessel Failure
Time frame: 12 months
Number of uncovered and/or malapposed stent struts at overlapping sites in sirolimus-, paclitaxel- or zotarolimus eluting stents
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2008.
- Background: PubMed 16814667Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.
- Background: PubMed 15998681Finn AV, Kolodgie FD, Harnek J, Guerrero LJ, Acampado E, Tefera K, Skorija K, Weber DK, Gold HK, Virmani R. Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents. Circulation. 2005 Jul 12;112(2):270-8. doi: 10.1161/CIRCULATIONAHA.104.508937. Epub 2005 Jul 5.
- Background: PubMed 17438147Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.
- Background: PubMed 17510464Finn AV, Nakazawa G, Joner M, Kolodgie FD, Mont EK, Gold HK, Virmani R. Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol. 2007 Jul;27(7):1500-10. doi: 10.1161/ATVBAHA.107.144220. Epub 2007 May 17.
- Background: PubMed 17950831Nakazawa G, Finn AV, John MC, Kolodgie FD, Virmani R. The significance of preclinical evaluation of sirolimus-, paclitaxel-, and zotarolimus-eluting stents. Am J Cardiol. 2007 Oct 22;100(8B):36M-44M. doi: 10.1016/j.amjcard.2007.08.020.
- Background: PubMed 17135281Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. doi: 10.1093/eurheartj/ehl413. Epub 2006 Nov 29.
- Background: PubMed 12591841Bouma BE, Tearney GJ, Yabushita H, Shishkov M, Kauffman CR, DeJoseph Gauthier D, MacNeill BD, Houser SL, Aretz HT, Halpern EF, Jang IK. Evaluation of intracoronary stenting by intravascular optical coherence tomography. Heart. 2003 Mar;89(3):317-20. doi: 10.1136/heart.89.3.317.
- Background: PubMed 17437723Takano M, Inami S, Jang IK, Yamamoto M, Murakami D, Seimiya K, Ohba T, Mizuno K. Evaluation by optical coherence tomography of neointimal coverage of sirolimus-eluting stent three months after implantation. Am J Cardiol. 2007 Apr 15;99(8):1033-8. doi: 10.1016/j.amjcard.2006.11.068. Epub 2007 Feb 23.
- Background: PubMed 18307999Yamaguchi T, Terashima M, Akasaka T, Hayashi T, Mizuno K, Muramatsu T, Nakamura M, Nakamura S, Saito S, Takano M, Takayama T, Yoshikawa J, Suzuki T. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical setting. Am J Cardiol. 2008 Mar 1;101(5):562-7. doi: 10.1016/j.amjcard.2007.09.116. Epub 2008 Jan 10.
- Derived from this study: PubMed 20488410Guagliumi G, Musumeci G, Sirbu V, Bezerra HG, Suzuki N, Fiocca L, Matiashvili A, Lortkipanidze N, Trivisonno A, Valsecchi O, Biondi-Zoccai G, Costa MA; ODESSA Trial Investigators. Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents. JACC Cardiovasc Interv. 2010 May;3(5):531-9. doi: 10.1016/j.jcin.2010.02.008.
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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.
Giulio Guagliumi, MD principal investigator
Cardiovascular Department Ospedali Riuniti di Bergamo
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 sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co), paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS) and zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA) in people with Coronary Artery Disease, run by A.O. Ospedale Papa Giovanni XXIII 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 5 inclusion and 7 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 6 Jun 2008. 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?
Contact Monia Lorini, MD (39-03-526-9751, mlorini@ospedaliriuniti.bergamo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of uncovered and/or malapposed stent struts at overlapping versus non overlapping sites in drug eluting vs bare metal stents (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 NCT00693030, which also lists 10 linked publications.
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 6 Jun 2008.