Sirolimus-eluting vs Zotarolimus-eluting Stents for Chronic Total Coronary Occlusions

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. Identifier: NCT00428454
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : June 4, 2015
Cordis Corporation
Information provided by (Responsible Party):
Dr. M.J. Suttorp, R&D Cardiologie

Brief Summary:
Primary intracoronary stent placement after successfully crossing chronic total coronary occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. In the PRISON II study we demonstrated that sirolimus-eluting stents were superior to bare metal stents in CTO. In this prospective randomized trial, sirolimus-stent implantation will be compared with zotarolimus-eluting stent implantation for the treatment of chronic total coronary occlusions. A total of 300 patients will be clinically followed up for 1, 6, 12 months, 2, 3, 4, 5 year with angiographic follow-up at 8 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is in-segment late luminal loss at 8 month angiographic follow-up.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Disease Coronary Stenosis Device: sirolimus-eluting stent, zotarolimus-eluting stent Phase 3

Detailed Description:
Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) was traditionally limited by high restenosis rates. Coronary stenting using bare metal stents significantly decreases restenosis in CTO compared to balloon angioplasty alone, but restenosis rates still reach 32-55%. In 200 patients with CTO, randomized in the PRISON I study we demonstrated a restenosis rate of 22% after bare metal stent (BMS) implantation as compared with 33% after conventional balloon angioplasty. During the past few years, sirolimus (rapamycin), a cytostatic macrocyclic lactone with anti-inflammatory and antiproliferative properties, delivered from a polymer-encapsulated stent was shown to almost eliminate the risk of restenosis in selected groups of patients. The drug zotarolimus (ABT-578), a sirolimus analogue, is designed to inhibit the cellular process that leads to restenosis. In the PRISON II study we have randomized 200 patients with CTO to either BMS implantation or sirolimus-eluting stent implantation and we demonstrated a reduction of in-stent binary restenosis from 36% to 7% and in-segment binary restenosis rates from 41% to 11% in favour of the sirolimus eluting stent. However, no data are available on direct comparison of the clinical efficacy, safety, and angiographic outcome of particular drug-eluting stents in patients with CTO and there may be differences between various drug-eluting stents. The PRISON III study is designed to address this issue and provide information about two different drug-eluting stents. It is a prospective randomized, single blinded trial comparing the relative safety, clinical efficacy and angiographic outcomes of sirolimus and zotarolimus-eluting stents in patients undergoing successful recanalization of CTO.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Sirolimus-eluting Stent Implantation With Zotarolimus-eluting Stent Implantation for the Treatment of Chronic Total Coronary Occlusions. The PRISON III Trial.
Study Start Date : January 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Zotarolimus eluting stent
Zotarolimus eluting stent
Device: sirolimus-eluting stent, zotarolimus-eluting stent
PCI in chronically occluded coronary artery
Active Comparator: Sirolimus eluting stent
Sirolimus eluting stent
Device: sirolimus-eluting stent, zotarolimus-eluting stent
PCI in chronically occluded coronary artery

Primary Outcome Measures :
  1. In-segment late luminal loss at 8 months as assessed by an independent angiographic core lab. [ Time Frame: 8 month ]

Secondary Outcome Measures :
  1. In-stent late luminal loss [ Time Frame: 8 month ]
  2. In-stent and in-segment binary restenosis rate [ Time Frame: 8 month ]
  3. In-stent and in-segment MLD [ Time Frame: 8 month ]
  4. Percentage diameter stenosis [ Time Frame: 8 month ]
  5. A composite of major adverse cardiac events (MACE: death, myocardial infarction and clinically driven target lesion revascularization) [ Time Frame: 8 month ]
  6. Stent thrombosis (acute, <1day; subacute, 1 to 30 days; and late, >30 days) [ Time Frame: 30 days ]
  7. Target vessel failure up to 5 year of clinical follow-up. [ Time Frame: 5 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • the estimated duration of the occlusion is at least 2 weeks.
  • signs of ischemia related to the occluded coronary artery.
  • successful recanalization of the occluded artery is achieved.
  • reference diameter is > 2.5 mm.
  • written informed consent obtained.


  • primary or rescue PCI for acute myocardial infarction
  • the lesion could not be crossed.
  • lesions with complex anatomy making successful stent deployment unlikely.
  • the guide wire is not in the true lumen distal to the occlusion.
  • Sirolimus or zotarolimus allergy
  • venous or arterial bypass grafts
  • pregnant or nursing women.
  • participation in an other trial.
  • factors making long-term follow-up difficult or unlikely.
  • life expectancy <1 year.
  • contraindications for ASA or Clopidogrel or heparin.
  • use of coumadins that could not be stopped before the procedure.

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 identifier (NCT number): NCT00428454

AZ Middelheim
Antwerpen, Belgium, 2020
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1090HM
Amsterdam, Netherlands, 1105AZ
Catharina Ziekenhuis
Eindhoven, Netherlands, 5602ZA
St Antonius Hospital
Nieuwegein, Netherlands, 3435CM
Sponsors and Collaborators
R&D Cardiologie
Cordis Corporation
Principal Investigator: Maarten J. Suttorp, MD, PhD St. Antonius Hospital


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. M.J. Suttorp, MD, PhD, FESC, FACC, R&D Cardiologie Identifier: NCT00428454     History of Changes
Other Study ID Numbers: RDC-2006-02
First Posted: January 30, 2007    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by Dr. M.J. Suttorp, R&D Cardiologie:
drug-eluting stent
chronic total occlusion
sirolimus-eluting stent
zotarolimus-eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs