Optical Coherence Tomography in Long Lesions

NCT01133925 | Unknown Phase 4 DMC

• 1 other identifier: BG-003-08
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (4)

• Rate of > 30% uncovered struts/total number of struts per section.

  6 months

• MACE Rates

  1-6 and 12 months

• IVUS parameters

  6 months

• QCA Parameters

  6 months

Study Arms (2)

ODESSA

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.

Device: Sirolimus Eluting Stent; Device: Paclitaxel Eluting Stent; Device: Zotarolimus eluting stent

Resolute Sprint arm

EXPERIMENTAL

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

Device: Resolute Sprint

Interventions

Resolute Sprint DEVICE

Zotarolimus Eluting Stent (Resolute Sprint) implanted in overlap

Resolute Sprint arm

Sirolimus Eluting Stent DEVICE

Cypher stents implanted in overlap

ODESSA

Paclitaxel Eluting Stent DEVICE

Taxus stents implanted in overlap

ODESSA

Zotarolimus eluting stent DEVICE

Endeavor stents implanted in overlap

ODESSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• A.O. Ospedale Papa Giovanni XXIII: lead
• Case Western Reserve University: collaborator
• Medtronic Vascular: collaborator

Study Sites (1)

Cardiovascular Department Ospedali Riuniti di Bergamo

Bergamo, BG, 24128, Italy

Location

Related Publications (2)

• 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.

  PMID: 20488410 BACKGROUND

• 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.

  PMID: 21777886 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Giulio Guagliumi, MD

  Cardiovascular Department Ospedali Riuniti di Bergamo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: May 31, 2010
• Study Start: May 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: May 1, 2011
• Last Updated: May 31, 2010

Record last verified: 2010-05

Locations

IT (1)