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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01200693
First Posted: September 14, 2010
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Francesco Burzotta, Catholic University of the Sacred Heart
  Purpose

BACKGROUND:

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:

  1. 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.
  2. 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.

  1. COMPARISON BETWEEN ZES, 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.

Condition Intervention Phase
Coronary Artery Disease Coronary Stenosis Device: Sirolimus eluting stent Device: Everolimus eluting stent Device: Zotarolimus eluting stent Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Z-SEA-SIDE: Sirolimus Versus Everolimus Versus Zotarolimus-eluting Stent Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis

Resource links provided by NLM:


Further study details as provided by Francesco Burzotta, Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • 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:

    1. occurrence of SB TIMI flow <3 after MV stenting throughout the procedure;
    2. need of guidewire(s) different from BMW to re-wire SB after MV stenting;
    3. failure to re-wire the SB after MV stenting;
    4. 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.


Secondary Outcome Measures:
  • 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)


Enrollment: 80
Study Start Date: November 2008
Study Completion Date: March 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Italy
Institute of Cardiology - Catholic University of Sacred Heart
Rome, Italy, 00100
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Francesco Burzotta, MD,PhD,FESC Catholic University of Sacred Heart
  More Information

Publications:
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.
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.
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.
Lefèvre T, Louvard Y, Morice MC, Loubeyre C, Piéchaud JF, Dumas P. Stenting of bifurcation lesions: a rational approach. J Interv Cardiol. 2001 Dec;14(6):573-85. Review.
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.
Valgimigli M, Malagutti P, Rodriguez Granillo GA, Tsuchida K, Garcia-Garcia HM, van Mieghem CA, Van der Giessen WJ, De Feyter P, de Jaegere P, Van Domburg RT, Serruys PW. Single-vessel versus bifurcation stenting for the treatment of distal left main coronary artery disease in the drug-eluting stenting era. Clinical and angiographic insights into the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) and Taxus-Stent Evaluated at Rotterdam Cardiology Hospital (T-SEARCH) registries. Am Heart J. 2006 Nov;152(5):896-902.
Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. Epub 2005 Sep 28. Review.
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.
Ge L, Iakovou I, Cosgrave J, Agostoni P, Airoldi F, Sangiorgi GM, Michev I, Chieffo A, Montorfano M, Carlino M, Corvaja N, Colombo A. Treatment of bifurcation lesions with two stents: one year angiographic and clinical follow up of crush versus T stenting. Heart. 2006 Mar;92(3):371-6. Epub 2005 Jun 17.
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.
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.
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.
Gradaus R, Mathies K, Breithardt G, Böcker D. Clinical assessment of a new real time 3D quantitative coronary angiography system: evaluation in stented vessel segments. Catheter Cardiovasc Interv. 2006 Jul;68(1):44-9.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Burzotta, MD, PhD, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01200693     History of Changes
Other Study ID Numbers: UCSC-002
First Submitted: June 10, 2010
First Posted: September 14, 2010
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Francesco Burzotta, Catholic University of the Sacred Heart:
Angioplasty, Transluminal, Percutaneous Coronary
Drug-Eluting Stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Constriction, Pathologic
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents


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