Optical Coherence Tomography in Long Lesions

Coronary Artery Disease Clinical Trial

— LONG OCT  

Official title:

Optical Coherence Tomography in Long Native Coronary Artery Lesions Treated With Multiple Novel Zotarolimus-eluting Stents: LONG OCT STUDY

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01133925
• Other study ID #: BG-003-08
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 28, 2010
• Last updated: May 28, 2010
• Start date: May 2008
• Est. completion date: May 2011

Study information

• Verified date: May 2010
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Monitoring Center for Clinical Trials-Ministry of Health
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: May 2011
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Resolute Sprint
Zotarolimus Eluting Stent (Resolute Sprint) implanted in overlap
• Sirolimus Eluting Stent
Cypher stents implanted in overlap
• Paclitaxel Eluting Stent
Taxus stents implanted in overlap
• Zotarolimus eluting stent
Endeavor stents implanted in overlap

Locations

Country	Name	City	State
Italy	Cardiovascular Department Ospedali Riuniti di Bergamo	Bergamo	BG

Sponsors (3)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII	Case Western Reserve University, Medtronic Vascular

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In stent NIH at overlapping vs non overlapping sites	In-stent neointimal hyperplasia (NIH) thickness at 6 months, as measured by OCT, at overlapping vs non overlapping sites: superiority of Endeavor Resolute stent compared to Endeavor Sprint	6 month	Yes
Primary	Percent uncovered and malapposed struts in OCT	Proportion of stent struts uncovered and/or malapposed at 6 months, as measured by OCT, at overlapping vs non overlapping sites: non inferiority of Endeavor Resolute compared to Endeavor Sprint.	6 month	Yes
Secondary	Rate of > 30% uncovered struts/total number of struts per section.		6 months	Yes
Secondary	MACE Rates	All specific components of MACE (cardiac death, myocardial infarction (Q wave and non Q wave), and target vessel revascularization) will be summarized. MACE shall be assessed at, discharge (or within 7 days, whichever comes first), 1, 6 and 12 months post index procedure.	1-6 and 12 months	Yes
Secondary	IVUS parameters	Based on IVUS Core Lab analysis including: Neointimal volume, stent volume, lumen volume and percent net volume obstruction; Neointimal Thickness: Neointimal hyperplasia (NIH) inside all struts (mean, median, max); Percent NIH Area= ([stent area-lumen area]/stent area) X 100; Rate of > 30% uncovered struts/total number of struts per section.	6 months	Yes
Secondary	QCA Parameters	Based on Angiographic Core Lab analysis utilizing Quantitative Coronary Angiography (QCA) including: Mean lumen diameter, acute gain, late loss through 6 months, and binary restenosis (= 50% diameter stenosis) rate at 6 months post index procedure.	6 months	Yes