NCT00220558

Brief Summary

The objective of this study is to compare the Cypher Select-TM Sirolimus Eluting Stent (SES) with the SONIC-TM Bare Metal Stent (BMS) in the treatment of Chronic Total Occlusion lesions (CTO). The primary hypothesis is that, at 8-month follow-up, the minimal luminal diameter (MLD) of the coronary segment treated with stent implantation in CTO lesions is significantly larger with the use of SES compared to BMS. The treated segment is defined as the segment covered by the stent(s) plus 5 mm proximally and distally to the stent(s).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started May 2005

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

December 4, 2009

Status Verified

May 1, 2009

Enrollment Period

2.4 years

First QC Date

September 14, 2005

Last Update Submit

December 3, 2009

Conditions

Coronary Artery Disease

Keywords

Percutaneous Transluminal Coronary AngioplastyBare metal stentsdrug eluting stents

Outcome Measures

Primary Outcomes (1)

  • The minimal luminal diameter (MLD) at 8-month follow-up of the coronary segment treated with stent implantation in CTO lesions. The treated segment is defined as the segment covered by the stent(s) plus 5 mm proximally and distally to the stent(s).

    8 month

Secondary Outcomes (10)

  • - Major adverse cardiac events (MACE) rate at 30 days, 8, 12 and 24 months;

    two years

  • - In-segment late loss (LL) at 8 months;

    8 months

  • - Binary restenosis rate in the treated coronary segment, defined as the rate of patients showing an in-segment diameter stenosis greater than 50% at 8 months;

    eight month

  • - In-segment total re-occlusion at 8 months;

    8 month

  • - Target Lesion Revascularization (TLR) at 8 ,12 and 24 months;

    two years

  • +5 more secondary outcomes

Interventions

Coronary placement of bare metal stent vs. drug eluting stentDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable or unstable angina pectoris or documented silent ischemia;
  • Planned treatment of a single de novo chronic totally occluded (CTO) in a native coronary artery with a reference diameter between 2.75 mm and 3.75 mm;
  • The target lesion can be fully covered by ≤ 2 stents of ≤33 mm of length each;
  • The target CTO is at least 30 days old;
  • The target CTO is successfully crossed by a guide wire and dilated by a balloon;

You may not qualify if:

  • Myocardial infarction within 30 days in the territory of the target CTO;
  • Unprotected left main coronary artery disease;
  • Target CTO is in a graft;
  • Target CTO is in a stented segment;
  • Presence of other lesions in the same vessel,requiring angioplasty and not treatable with the same stent(s) used for the target CTO;
  • More than one CTO requiring PCI;
  • Target CTO has diseased side branches \>2.0 mm in diameter;
  • Target CTO pretreated with non-balloon devices such as atherectomy or laser or thrombectomy devices;
  • Patient treated with coronary brachytherapy;
  • The patient has an ejection fraction ≤ 30%;
  • The patient has impaired renal function (creatinine \> 3.0 mg/dl);
  • The patient has known allergies to aspirin, clopidogrel bisulfate and ticlopidine, heparin, or sirolimus, contrast media or stainless steel that cannot be managed medically;
  • The patient needs therapy with warfarin;
  • The patient has a life expectancy less than 24 months;
  • Recipient of heart transplant;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Ospedale San Donato

Arezzo, 52100, Italy

Location

Cliniche Gavazzeni

Bergamo, Italy

Location

Ospedale Sant'Orsola-Malpighi

Bologna, 40138, Italy

Location

Ospedale Vittorio Emanuele

Catania, 95124, Italy

Location

Ospedale Sant'Anna

Como, 22100, Italy

Location

Azienda Ospedaliera Villa Scassi

Genoa, 16149, Italy

Location

Ospedale San Martino

Genova, 16132, Italy

Location

Ospedale Civile di Legnano

Legnano, 20025, Italy

Location

Ospedale Civile di Mestre

Mestre, 30174, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Azienda Ospedaliera Pisana

Pisa, 56127, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, 42100, Italy

Location

Ospedale San Giovanni Battista Università

Torino, 10143, Italy

Location

Ospedale Cà Foncello

Treviso, 31100, Italy

Location

Related Publications (4)

  • Rubartelli P, Niccoli L, Verna E, Giachero C, Zimarino M, Fontanelli A, Vassanelli C, Campolo L, Martuscelli E, Tommasini G. Stent implantation versus balloon angioplasty in chronic coronary occlusions: results from the GISSOC trial. Gruppo Italiano di Studio sullo Stent nelle Occlusioni Coronariche. J Am Coll Cardiol. 1998 Jul;32(1):90-6. doi: 10.1016/s0735-1097(98)00193-4.

    PMID: 9669254BACKGROUND

  • Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.

    PMID: 14523139BACKGROUND

  • Hoye A, Tanabe K, Lemos PA, Aoki J, Saia F, Arampatzis C, Degertekin M, Hofma SH, Sianos G, McFadden E, van der Giessen WJ, Smits PC, de Feyter PJ, van Domburg RT, Serruys PW. Significant reduction in restenosis after the use of sirolimus-eluting stents in the treatment of chronic total occlusions. J Am Coll Cardiol. 2004 Jun 2;43(11):1954-8. doi: 10.1016/j.jacc.2004.01.045.

    PMID: 15172397BACKGROUND

  • Rubartelli P, Petronio AS, Guiducci V, Sganzerla P, Bolognese L, Galli M, Sheiban I, Chirillo F, Ramondo A, Bellotti S; Gruppo Italiano di Studio sullo Stent nelle Occlusioni Coronariche II GISE Investigators. Comparison of sirolimus-eluting and bare metal stent for treatment of patients with total coronary occlusions: results of the GISSOC II-GISE multicentre randomized trial. Eur Heart J. 2010 Aug;31(16):2014-20. doi: 10.1093/eurheartj/ehq199. Epub 2010 Jun 20.

    PMID: 20566487DERIVED

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Paolo Rubartelli, MD

    Azienda Ospedaliera Villa Scassi - Genoa - Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

May 1, 2005

Primary Completion

October 1, 2007

Study Completion

February 1, 2010

Last Updated

December 4, 2009

Record last verified: 2009-05

Locations

IT(14)