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Coronary Artery DiseasePhase 4NCT00220558

GISSOC II: Sirolimus Eluting Stent Versus Bare Metal Stent in Chronic Total Coronary Occlusions

A Phase 4 study testing Coronary placement of bare metal stent vs. drug eluting stent in people with Coronary Artery Disease, run by Società Italiana di Cardiologia Invasiva at 14 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Coronary placement of bare metal stent vs. drug eluting stent
Type of treatment
Medical device
How many people
150 participants
Where
14 sitesItaly
Study dates
May 2005to Feb 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 16Show fewer
  • 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;
  • The patient is currently participating in an investigational drug or another device study.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Italy14 sites

  • Ospedale San Donato

    Arezzo, 52100

  • Cliniche Gavazzeni

    Bergamo

  • Ospedale Sant'Orsola-Malpighi

    Bologna, 40138

  • Ospedale Vittorio Emanuele

    Catania, 95124

  • Ospedale Sant'Anna

    Como, 22100

  • Azienda Ospedaliera Villa Scassi

    Genoa, 16149

  • Ospedale San Martino

    Genova, 16132

  • Ospedale Civile di Legnano

    Legnano, 20025

  • Ospedale Civile di Mestre

    Mestre, 30174

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Azienda Ospedaliera Pisana

    Pisa, 56127

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100

  • Ospedale San Giovanni Battista Università

    Torino, 10143

  • Ospedale Cà Foncello

    Treviso, 31100

Other trials in Italy

About this study

Official title: A Randomized Comparison of Sirolimus Eluting Stent Versus Bare Metal Stent in Chronic Total Coronary Occlusions: The Gruppo Italiano di Studio Sullo Stent Nelle Occlusioni Coronariche. The GISSOC II Study.

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).

Read the detailed description

This is a multicenter, prospective, randomized study that will be conducted at up to 22 centers in Italy. All patients who meet the eligibility criteria will be randomized to Cypher Select-TM Stent or SONIC-TM Stent. Patients will have repeat angiography at 8 months and clinical follow-up to 2 years. The study population will consist of 150 patients with single chronic total occlusion in a native coronary artery with a reference diameter between 2.75 mm and 3.75 mm. The occlusion has to be dilatable by balloon angioplasty and can be fully covered by < 2 stents of ≤33 mm of length each. The CTO is defined as obstruction of a native coronary artery, at least 30 days old, with no luminal continuity and with Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 or 1. Following confirmation of eligibility criteria and successful pre-dilating of the CTO, patients will be randomized in a 1:1 ratio to receive SES CYPHER SELECT Stent or BMS SONIC Stent.

The coronary angiograms will be assessed at a core laboratory with Quantitative Coronary Angiography. Quantitative angiographic parameters including minimal luminal diameter, binary restenosis rate, total reocclusion rate, late luminal loss, will be evaluated at 8 months. The incidence of clinical events, including death, myocardial infarction, target vessel revascularization, stent thrombosis, will be evaluated at 8, 12 and 24 months.

Being tested
Coronary placement of bare metal stent vs. drug eluting stent
Keywords
Percutaneous Transluminal Coronary Angioplasty, Bare metal stents, drug eluting stents
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Coronary placement of bare metal stent vs. drug eluting stentDevice

What is being measured

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

  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).

    Measured: 8 month

Secondary outcomes (10)

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

    Measured: two years

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

    Measured: 8 months

  3. - 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;

    Measured: eight month

  4. - In-segment total re-occlusion at 8 months;

    Measured: 8 month

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

    Measured: two years

  6. - Target Vessel Revascularization (TVR) at 8 ,12 and 24 months;

    Measured: two years

  7. - Angiographic success defined as achievement of a final residual diameter stenosis of < 30 % (by QCA)using the assigned study stent;

    Measured: procedure date

  8. - Procedural success defined as angiographic success, without the occurrence of death, myocardial infarction (MI), or repeat revascularization of the target lesion during the hospital stay;

    Measured: procedure date

  9. - Sub acute stent thrombosis defined as angiographic documentation <30 days after the index procedure (site-reported or by QCA) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel;

    Measured: one month

  10. - Late stent thrombosis defined as angiographic documentation >30 days after the index procedure (site-reported or by QCA) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.

    Measured: two yeras

Timeline

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

  1. First posted22 Sep 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionOct 2007
  4. Study completionFeb 2010 (estimated)

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
NCT00220558
Sponsor's protocol ID
CRDIT 00-01/04
Status last verified
May 2009
First submitted
14 Sep 2005
Last updated
4 Dec 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 9669254

  • 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.

    PubMed 14523139

  • 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.

    PubMed 15172397

  • 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.

    PubMed 20566487

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Coronary placement of bare metal stent vs. drug eluting stent in people with Coronary Artery Disease, run by Società Italiana di Cardiologia Invasiva at 14 sites 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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 4 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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?

Results are not available in the source record.

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?

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). (time frame: 8 month). 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 NCT00220558, which also lists 4 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 4 Dec 2009.

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