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Coronary Artery DiseasePhase 4SEA-SIDENCT00697372

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

A Phase 4 study testing Sirolimus eluting stent and Everolimus eluting stent in people with Coronary Artery Disease and Coronary Stenosis, run by Catholic University of the Sacred Heart at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Artery Disease, Coronary Stenosis
What is being tested?
Sirolimus eluting stent and Everolimus eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteItaly
Study dates
Sep 2007to Apr 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Institute of Cardiology - Catholic University of Sacred Heart

    Rome, 00168

Other trials in Italy

About this study

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.

Read more

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.
Read the detailed description

Bifurcated lesions are challenging target lesions in percutaneous coronary interventions (PCI) which may specifically benefit from the usage of drug-eluting stents (DES). However, the selection of the type of DES and the technique for DES implantation have not been clarified. In spite of the technique adopted, 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 as this is not associated with worse outcome compared to more complex stenting strategies. 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 (as a measure of the impact of stent design) and the late clinical outcome of Sirolimus-eluting (SES) vs Everolimus-eluting stent (EES) obtained using a provisional TAP-stenting approach to treat bifurcated lesions.
  2. to prospectively assess the clinical relevance (in terms of inducible ischemia) of suboptimal angiographic result in the SB of bifurcated lesions treated by 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 details, post-PCI cardiac enzyme release, clinical outcome up to 1 year will be prospectively recorded. After the procedure, the subgroup of patients in which complete revascularization has been achieved (no untreated stenosis >50% in any other vessel, no residual stenosis >50% in any other treated vessel), will enter a systematic assessment of inducible ischemia by early (<8 days) and late (6-month) 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% and 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": comparison of the 3DQCA-estimated MLD and MLA in the SB.
  • "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 (TBF) defined as target bifurcation-related major adverse coronary events (MACE) or target bifurcation angiographic failure.
  1. SB-RELATED ISCHAEMIA of Group O vs Group S in patients with complete revascularization: inducible ischemia (diagnostic ST-segment changes) at the early (<8 days) exercise test or occurrence of early (<12 weeks) spontaneous ischemia related to the SB (any ischemic episode requiring unplanned coronary angiography with documentation of main vessel patency).
Being tested
Sirolimus eluting stent, Everolimus eluting stent
Keywords
Angioplasty, Transluminal, Percutaneous Coronary, Drug-Eluting Stents
Medical subject headings
Coronary Artery Disease, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sirolimus eluting stentDevice

    Also called Cypher stent - Cordis (Johnson&Johnson Company)

    Implantation of Sirolimus eluting stent

  • Everolimus eluting stentDevice

    Also called Xience stent - Abbot company

    Implantation of Everolimus eluting stent

Study groups in NCT00697372
Study groupRoleWhat they receive
SESActive comparatorPatients with coronary bifurcation lesions treated by Sirolimus eluting stent
Receives: Device: Sirolimus eluting stent
EESActive comparatorPatients with coronary bifurcation lesions treated by Everolimus eluting stent
Receives: Device: Everolimus eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-9-12-18 MONTH CLINICAL OUTCOME (Comparison of the rate of target bifurcation failure)

    Measured: 18 MONTHS

  2. 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.

    Measured: 7 DAYS

  3. SIDE BRANCH TROUBLE

    "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.

    Measured: 7 DAYS

  4. TARGET BIFURCATION FAILURE

    • target bifurcation failure (TBF) defined as target bifurcation-related major adverse coronary events (MACE) or target bifurcation angiographic failure.

    Measured: 18 MONTHS

Secondary outcomes (1)

  1. 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)

    Measured: 7 DAYS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionOct 2008
  4. Study completionApr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00697372
Sponsor's protocol ID
P648
Acronym
SEA-SIDE
Status last verified
Jun 2010
First submitted
11 Jun 2008
Last updated
15 Jun 2010
Results posted
No
Data monitoring committee
No

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. doi: 10.1161/01.CIR.0000118474.71662.E3. Epub 2004 Feb 23.

    PubMed 14981005

  • 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. doi: 10.1002/ccd.20453.

    PubMed 16003787

  • Pan M, Suarez 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. doi: 10.1016/j.ahj.2006.10.017.

    PubMed 17174630

  • Lefevre T, Louvard Y, Morice MC, Loubeyre C, Piechaud JF, Dumas P. Stenting of bifurcation lesions: a rational approach. J Interv Cardiol. 2001 Dec;14(6):573-85. doi: 10.1111/j.1540-8183.2001.tb00375.x.

    PubMed 12053378

  • 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. doi: 10.1016/j.amjcard.2004.11.030.

    PubMed 15757605

  • 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. doi: 10.1016/j.ahj.2006.03.029.

    PubMed 17070153

  • Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. doi: 10.1016/j.jacc.2005.05.080. Epub 2005 Sep 28.

    PubMed 16226167

  • Pan M, de Lezo JS, Medina A, Romero M, Segura J, Pavlovic D, Delgado A, Ojeda S, Melian F, Herrador J, Urena 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. doi: 10.1016/j.ahj.2004.05.029.

    PubMed 15523318

  • 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. doi: 10.1136/hrt.2005.061531. Epub 2005 Jun 17.

    PubMed 15964941

  • Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Niemela M, Kervinen K, Jensen JS, Galloe A, Nikus K, Vikman S, Ravkilde J, James S, Aaroe J, Ylitalo A, Helqvist S, Sjogren 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. doi: 10.1161/CIRCULATIONAHA.106.664920. Epub 2006 Oct 23.

    PubMed 17060387

  • 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. doi: 10.1016/j.jacc.2005.04.054.

    PubMed 16098427

  • 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. doi: 10.1002/ccd.21194.

    PubMed 17585382

  • Gradaus R, Mathies K, Breithardt G, Bocker 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. doi: 10.1002/ccd.20775.

    PubMed 16770813

  • Burzotta F, Trani C, Todaro D, Lanza GA, Mariani L, Tommasino A, Niccoli G, Porto I, Leone AM, Crea F. Prospective evaluation of myocardial ischemia related to post-procedural side-branch stenosis in bifurcated lesions treated by provisional approach with drug-eluting stents. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):351-9. doi: 10.1002/ccd.23218. Epub 2011 Dec 12.

    PubMed 21735527

  • Burzotta F, Trani C, Todaro D, Mariani L, Talarico GP, Tommasino A, Giammarinaro M, Niccoli G, Porto I, Leone AM, Mongiardo R, Mazzari MA, Schiavoni G, Crea F. Prospective randomized comparison of sirolimus- or everolimus-eluting stent to treat bifurcated lesions by provisional approach. JACC Cardiovasc Interv. 2011 Mar;4(3):327-35. doi: 10.1016/j.jcin.2010.12.005.

    PubMed 21435612

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sirolimus eluting stent and Everolimus eluting stent in people with Coronary Artery Disease and Coronary Stenosis, run by Catholic University of the Sacred Heart at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-9-12-18 MONTH CLINICAL OUTCOME (Comparison of the rate of target bifurcation failure) (time frame: 18 MONTHS). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00697372, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2010.

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