Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments resolute sprint, sirolimus eluting stent, paclitaxel eluting stent, zotarolimus eluting stent
Phase phase 4
Sponsor A.O. Ospedale Papa Giovanni XXIII
Collaborator Case Western Reserve University
Start date May 2008
End date August 2009
Trial size 22 participants
Trial identifier NCT01133925, BG-003-08

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. 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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
sirolimus eluting stent
Cypher stents implanted in overlap
paclitaxel eluting stent
Taxus stents implanted in overlap
zotarolimus eluting stent
Endeavor stents implanted in overlap
(Experimental)
Zotarolimus Eluting stents (Resolute Sprint) implanted in overlap to treat long coronary lesions
resolute sprint
Zotarolimus Eluting Stent (Resolute Sprint) implanted in overlap

Primary Outcomes

Measure
In stent NIH at overlapping vs non overlapping sites
time frame: 6 month
Percent uncovered and malapposed struts in OCT
time frame: 6 month

Secondary Outcomes

Measure
Rate of > 30% uncovered struts/total number of struts per section.
time frame: 6 months
MACE Rates
time frame: 1-6 and 12 months
IVUS parameters
time frame: 6 months
QCA Parameters
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Optical Coherence Tomography in Long Native Coronary Artery Lesions Treated With Multiple Novel Zotarolimus-eluting Stents: LONG OCT STUDY
Principal investigator Giulio Guagliumi, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by A.O. Ospedale Papa Giovanni XXIII.