Z-SEA-SIDE: Sirolimus Versus Everolimus Versus Zotarolimus-eluting Stent Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis (Z-SEA-SIDE)
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|ClinicalTrials.gov Identifier: NCT01200693|
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : February 15, 2013
Bifurcated lesions are a challenging subset in percutaneous coronary interventions (PCI). The selection of the type of drug-eluting stents (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:
- to compare in a prospective study the acute 3D angiographic results and the late clinical outcome of Sirolimus-eluting (SES) vs Everolimus-eluting (EES) vs Zotarolimus eluting stent (ZES) obtained using a provisional TAP-stenting technique.
- to prospectively assess the clinical relevance (inducible ischemia) of suboptimal angiographic result in the SB after stenting.
METHODS TO BE APPLIED:
75 consecutive patients with bifurcated lesions undergoing PCI with the provisional T-and-small-protruding (TAP) technique with ZES implantation will be enrolled. 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 quantitative coronary angiography (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%.
For the comparison among SES and EES, data will be obtained from the randomized trial SEA-SIDE (NCT00697372).
PRIMARY STUDY END-POINTS.
COMPARISON BETWEEN ZES, SES AND EES:
SB acute angiographic result; SB trouble; target bifurcation failure.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Coronary Stenosis||Device: Sirolimus eluting stent Device: Everolimus eluting stent Device: Zotarolimus eluting stent||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Z-SEA-SIDE: Sirolimus Versus Everolimus Versus Zotarolimus-eluting Stent Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||March 2012|
Active Comparator: ZES
Patients with coronary bifurcation lesions treated by Zotarolimus eluting stent
Device: Zotarolimus eluting stent
Implantation of Zotarolimus eluting stent
Other Name: Endeavor Resolute stent - Medtronic company
Active Comparator: SES
Patients with coronary bifurcation lesions treated by Sirolimus eluting stent
Device: Sirolimus eluting stent
Implantation of Sirolimus eluting stent
Other Name: Cypher stent - Cordis (Johnson&Johnson Company)
Active Comparator: EES
Patients with coronary bifurcation lesions treated by Everolimus eluting stent
Device: Everolimus eluting stent
Implantation of Everolimus eluting stent
Other Name: Xience stent - Abbot company
- 6-9-12-18 MONTH CLINICAL OUTCOME [ Time Frame: 18 MONTHS ]
- ACUTE ANGIOGRAPHIC RESULT [ Time Frame: 7 DAYS ]
- "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.
- SIDE BRANCH TROUBLE [ Time Frame: 7 DAYS ]
"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.
- TARGET BIFURCATION FAILURE [ Time Frame: 18 MONTHS ]- target bifurcation failure (TBF) defined as target bifurcation-related major adverse coronary events (MACE) or target bifurcation angiographic failure.
- TECHNICAL CHARACTERISTICS [ Time Frame: 7 DAYS ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200693
|Institute of Cardiology - Catholic University of Sacred Heart|
|Rome, Italy, 00100|
|Principal Investigator:||Francesco Burzotta, MD,PhD,FESC||Catholic University of Sacred Heart|