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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by R&D Cardiologie.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Cordis Corporation
Information provided by (Responsible Party):
Dr. M.J. Suttorp, R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT00428454
First received: January 29, 2007
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Coronary Artery Disease
Coronary Disease
Coronary Stenosis
Device: sirolimus-eluting stent, zotarolimus-eluting stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by R&D Cardiologie:

Primary Outcome Measures:
  • In-segment late luminal loss at 8 months as assessed by an independent angiographic core lab. [ Time Frame: 8 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In-stent late luminal loss [ Time Frame: 8 month ] [ Designated as safety issue: No ]
  • In-stent and in-segment binary restenosis rate [ Time Frame: 8 month ] [ Designated as safety issue: No ]
  • In-stent and in-segment MLD [ Time Frame: 8 month ] [ Designated as safety issue: No ]
  • Percentage diameter stenosis [ Time Frame: 8 month ] [ Designated as safety issue: No ]
  • A composite of major adverse cardiac events (MACE: death, myocardial infarction and clinically driven target lesion revascularization) [ Time Frame: 8 month ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (acute, <1day; subacute, 1 to 30 days; and late, >30 days) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Target vessel failure up to 5 year of clinical follow-up. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2007
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • 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.

EXCLUSION CRITERIA

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428454

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. M.J. Suttorp, MD, PhD, FESC, FACC, R&D Cardiologie
ClinicalTrials.gov Identifier: NCT00428454     History of Changes
Other Study ID Numbers: RDC-2006-02
Study First Received: January 29, 2007
Last Updated: January 31, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by R&D Cardiologie:
drug-eluting stent
chronic total occlusion
sirolimus-eluting stent
zotarolimus-eluting stent
QCA

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

ClinicalTrials.gov processed this record on August 18, 2014