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Optical Coherence Tomography in Long Lesions

NCT ID: NCT01133925

Last Updated: 2010-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-05-31

Brief Summary

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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 assigned to receive multiple zotarolimus eluting stents (Resolute Sprint). The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up.Data will be compared to the historical arm of ODESSA trial (patients treated with multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents).

Detailed Description

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It is not unknown whether overlapping drug-eluting stents provide increased vessel toxicity. 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 detects 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 assigned to receive multiple Resolute Sprint™. 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.

Obtained data will be compared with the data from a historical comparator (ODESSA trial that presented results from TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ stents implanted in overlap to treat long lesions.

Conditions

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Coronary Artery Disease

Keywords

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Coronary Artery Disease Percutaneous Coronary Intervention Drug Eluting Stent Optical Coherence Tomography Thrombosi Long lesions in native vessels requiring overlap

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ODESSA

ODESSA trial (NCT 00693030)Patients were randomized (2:2:2:1) to receive multiple TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ vs Libertè BM stents, in overlap. At 6-months follow-up coronary angiography (QCA), IVUS and Optical Coherence Tomography assessments were made. Data reported in J. Am. Coll. Cardiol. Intv. 2010;3;531-539. DOI 10.1016/j.jcin.2010.02.008.

Group Type ACTIVE_COMPARATOR

Sirolimus Eluting Stent

Intervention Type DEVICE

Cypher stents implanted in overlap

Paclitaxel Eluting Stent

Intervention Type DEVICE

Taxus stents implanted in overlap

Zotarolimus eluting stent

Intervention Type DEVICE

Endeavor stents implanted in overlap

Resolute Sprint arm

Zotarolimus Eluting stents (Resolute Sprint) implanted in overlap to treat long coronary lesions

Group Type EXPERIMENTAL

Resolute Sprint

Intervention Type DEVICE

Zotarolimus Eluting Stent (Resolute Sprint) implanted in overlap

Interventions

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Resolute Sprint

Zotarolimus Eluting Stent (Resolute Sprint) implanted in overlap

Intervention Type DEVICE

Sirolimus Eluting Stent

Cypher stents implanted in overlap

Intervention Type DEVICE

Paclitaxel Eluting Stent

Taxus stents implanted in overlap

Intervention Type DEVICE

Zotarolimus eluting stent

Endeavor stents implanted in overlap

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient must be at least 18 years of age
* Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
* Native coronary artery disease with \>75% diameter stenosis (no prior stent implant, no prior brachytherapy)
* Lesion length \> 20 mm
* Vessel size between 2.5 and 3.5 mm
* Multiple, overlapped Endeavor Resolute stents placement (intention to overlap \> 4 mm).

Exclusion Criteria

* Left main coronary artery disease
* Lesions in coronary artery bypass grafts
* Acute myocardial infarction
* Killip class IV
* Recent major bleeding (6 months)
* Renal failure with creatinine value \> 2.5 mg/dl
* Left ventricular global ejection fraction ≤ 30%.
* Allergy to aspirin and or clopidogrel/ticlopidine
* Patient in anticoagulant therapy
* No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels \[\> 3.5 mm in diameter\])
* Target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy) \< 9 months prior to index procedure
* Target lesion restenotic from previous stent implantation
* Any lesion (target or non-target) that has been previously treated with brachytherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Western Reserve University

OTHER

Sponsor Role collaborator

Medtronic Vascular

INDUSTRY

Sponsor Role collaborator

A.O. Ospedale Papa Giovanni XXIII

OTHER

Sponsor Role lead

Responsible Party

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Cardiovascular Department Ospedali Riuniti di Bergamo, Italy

Principal Investigators

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Giulio Guagliumi, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Department Ospedali Riuniti di Bergamo

Locations

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Cardiovascular Department Ospedali Riuniti di Bergamo

Bergamo, BG, Italy

Site Status

Countries

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Italy

References

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Guagliumi 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.

Reference Type BACKGROUND
PMID: 20488410 (View on PubMed)

Guagliumi G, Ikejima H, Sirbu V, Bezerra H, Musumeci G, Lortkipanidze N, Fiocca L, Tahara S, Vassileva A, Matiashvili A, Valsecchi O, Costa M. Impact of drug release kinetics on vascular response to different zotarolimus-eluting stents implanted in patients with long coronary stenoses: the LongOCT study (Optical Coherence Tomography in Long Lesions). JACC Cardiovasc Interv. 2011 Jul;4(7):778-85. doi: 10.1016/j.jcin.2011.04.007.

Reference Type DERIVED
PMID: 21777886 (View on PubMed)

Other Identifiers

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BG-003-08

Identifier Type: -

Identifier Source: org_study_id