Coronary Artery Disease Clinical Trial
— SEA-SIDEOfficial title:
SEA-SIDE: Sirolimus Versus Everolimus-eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis
Verified date | June 2010 |
Source | Catholic University of the Sacred Heart |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
BACKGROUND:
Bifurcated lesions are a challenging subset in percutaneous coronary interventions (PCI).
The selection of the type of DES and the technique for stent implantation have not been
clarified. The side-branch (SB) is emerging as critical point, accounting for more than a
third of the significant restenosis in the DES era. A series of data supports the adoption
of a conservative strategy: stenting the main vessel (MV) only and reserving a conservative
approach on the SB. Yet, the clinical relevance in terms of inducible ischemia of
sub-optimal angiographic result has not been clarified.
AIMS OF THE STUDY:
The aims of the present study are:
1. to compare in a prospective randomized study the acute 3D angiographic results and the
late clinical outcome of Sirolimus-eluting (SES) vs Everolimus-eluting stent (EES)
obtained using a provisional TAP-stenting technique.
2. to prospectively assess the clinical relevance (inducible ischemia) of suboptimal
angiographic result in the SB after stenting.
METHODS TO BE APPLIED:
150 consecutive patients with bifurcated lesions undergoing PCI with the provisional
TAP-stenting technique will be randomized to SES or EES implantation. Procedural and
post-PCI details will be prospectively recorded. The subgroup of patients in which complete
revascularization has been achieved will enter a systematic assessment of inducible ischemia
by early and late exercise tests.
Off line 3D QCA assessment will be performed and used to divide the study population in 2
groups according to the SB residual stenosis:
- Group O (optimal SB angiographic result): post-PCI SB area stenosis<50%
- Group S (sub-optimal SB angiographic result): post-PCI SB area stenosis>50%.
PRIMARY STUDY END-POINTS.
1. COMPARISON BETWEEN SES AND EES:
SB acute angiographic result; SB trouble; target bifurcation failure.
2. SB-RELATED ISCHAEMIA of Group O vs Group S in patients with complete revascularization:
inducible ischemia at the early exercise test or occurrence of early spontaneous
ischemia related to the SB.
Status | Completed |
Enrollment | 150 |
Est. completion date | April 2010 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - de novo bifurcated lesions - lesions >50% located in a major bifurcation point - TIMI >2 on both main vessel and side branch - main vessel visual diameter >2.5 mm - side branch visual diameter >2.0 mm - >18 years of age - signed the informed consent to enter the study Exclusion Criteria: - known hypersensitivity to Sirolimus, Everolimus, cobalt, chromium, nickel, tungsten acrylic and fluoro-polymers - contraindications to double antiplatelet therapy acute (within 48 hours) ST-elevation acute myocardial infarction |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Institute of Cardiology - Catholic University of Sacred Heart | Rome |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart |
Italy,
Burzotta F, Gwon HC, Hahn JY, Romagnoli E, Choi JH, Trani C, Colombo A. Modified T-stenting with intentional protrusion of the side-branch stent within the main vessel stent to ensure ostial coverage and facilitate final kissing balloon: the T-stenting and small protrusion technique (TAP-stenting). Report of bench testing and first clinical Italian-Korean two-centre experience. Catheter Cardiovasc Interv. 2007 Jul 1;70(1):75-82. — View Citation
Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR Jr, Spanos V, Louvard Y, Desmedt B, Di Mario C, Leon MB. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation. 2004 Mar 16;109(10):1244-9. Epub 2004 Feb 23. — View Citation
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Ge L, Tsagalou E, Iakovou I, Sangiorgi GM, Corvaja N, Airoldi F, Chieffo A, Montorfano M, Michev I, Colombo A. In-hospital and nine-month outcome of treatment of coronary bifurcational lesions with sirolimus-eluting stent. Am J Cardiol. 2005 Mar 15;95(6):757-60. — View Citation
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Koo BK, Kang HJ, Youn TJ, Chae IH, Choi DJ, Kim HS, Sohn DW, Oh BH, Lee MM, Park YB, Choi YS, Tahk SJ. Physiologic assessment of jailed side branch lesions using fractional flow reserve. J Am Coll Cardiol. 2005 Aug 16;46(4):633-7. — View Citation
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Ormiston JA, Webster MW, El Jack S, Ruygrok PN, Stewart JT, Scott D, Currie E, Panther MJ, Shaw B, O'Shaughnessy B. Drug-eluting stents for coronary bifurcations: bench testing of provisional side-branch strategies. Catheter Cardiovasc Interv. 2006 Jan;67(1):49-55. — View Citation
Pan M, de Lezo JS, Medina A, Romero M, Segura J, Pavlovic D, Delgado A, Ojeda S, Melián F, Herrador J, Ureña I, Burgos L. Rapamycin-eluting stents for the treatment of bifurcated coronary lesions: a randomized comparison of a simple versus complex strategy. Am Heart J. 2004 Nov;148(5):857-64. — View Citation
Pan M, Suárez de Lezo J, Medina A, Romero M, Delgado A, Segura J, Ojeda S, Mazuelos F, Hernandez E, Melian F, Pavlovic D, Esteban F, Herrador J. Drug-eluting stents for the treatment of bifurcation lesions: a randomized comparison between paclitaxel and sirolimus stents. Am Heart J. 2007 Jan;153(1):15.e1-7. — View Citation
Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Niemelä M, Kervinen K, Jensen JS, Galløe A, Nikus K, Vikman S, Ravkilde J, James S, Aarøe J, Ylitalo A, Helqvist S, Sjögren I, Thayssen P, Virtanen K, Puhakka M, Airaksinen J, Lassen JF, Thuesen L; Nordic PCI Study Group. Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation. 2006 Oct 31;114(18):1955-61. Epub 2006 Oct 23. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6-9-12-18 MONTH CLINICAL OUTCOME (Comparison of the rate of target bifurcation failure) | 18 MONTHS | No | |
Primary | ACUTE ANGIOGRAPHIC RESULT | "MV acute angiographic result": comparison of the 3DQCA-estimated MLD and MLA in the MV. "SB acute angiographic result": comparison of the 3DQCA-estimated MLD and MLA in the SB. |
7 DAYS | No |
Primary | SIDE BRANCH TROUBLE | "SB trouble" composite of: occurrence of SB TIMI flow <3 after MV stenting throughout the procedure; need of guidewire(s) different from BMW to re-wire SB after MV stenting; failure to re-wire the SB after MV stenting; failure to dilate the SB after MV stenting and SB re-wiring. |
7 DAYS | No |
Primary | TARGET BIFURCATION FAILURE | - target bifurcation failure (TBF) defined as target bifurcation-related major adverse coronary events (MACE) or target bifurcation angiographic failure. | 18 MONTHS | No |
Secondary | TECHNICAL CHARACTERISTICS | comparison of procedural time, fluoroscopy time, total x-ray exposure, contrast media volume usage, number of guidewires used to wire the SB, direct stenting failure rate, kissing balloon rate, occurrence of transient deterioration of blood flow through the SB (TIMI<3) | 7 DAYS | No |
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