Z-SEA-SIDE: Sirolimus Versus Everolimus Versus Zotarolimus-eluting Stent Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francesco Burzotta, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01200693
First received: June 10, 2010
Last updated: February 13, 2013
Last verified: February 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • 6-9-12-18 MONTH CLINICAL OUTCOME [ Time Frame: 18 MONTHS ] [ Designated as safety issue: Yes ]
  • ACUTE ANGIOGRAPHIC RESULT [ Time Frame: 7 DAYS ] [ Designated as safety issue: No ]
    • "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 ] [ Designated as safety issue: No ]

    "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 ] [ Designated as safety issue: No ]
    - 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:

Additional 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
Study First Received: June 10, 2010
Last Updated: February 13, 2013
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 17, 2014