NCT00428454

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
301

participants targeted

Target at P50-P75 for phase_3 coronary-artery-disease

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_3 coronary-artery-disease

Geographic Reach
2 countries

5 active sites

Status
completed

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

January 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

3.9 years

First QC Date

January 29, 2007

Last Update Submit

June 3, 2015

Conditions

Coronary Artery DiseaseCoronary DiseaseCoronary Stenosis

Keywords

drug-eluting stentchronic total occlusionsirolimus-eluting stentzotarolimus-eluting stentQCA

Outcome Measures

Primary Outcomes (1)

  • In-segment late luminal loss at 8 months as assessed by an independent angiographic core lab.

    8 month

Secondary Outcomes (7)

  • In-stent late luminal loss

    8 month

  • In-stent and in-segment binary restenosis rate

    8 month

  • In-stent and in-segment MLD

    8 month

  • Percentage diameter stenosis

    8 month

  • A composite of major adverse cardiac events (MACE: death, myocardial infarction and clinically driven target lesion revascularization)

    8 month

  • +2 more secondary outcomes

Study Arms (2)

Zotarolimus eluting stent

EXPERIMENTAL

Zotarolimus eluting stent

Device: sirolimus-eluting stent, zotarolimus-eluting stent

Sirolimus eluting stent

ACTIVE COMPARATOR

Sirolimus eluting stent

Device: sirolimus-eluting stent, zotarolimus-eluting stent

Interventions

sirolimus-eluting stent, zotarolimus-eluting stentDEVICE

PCI in chronically occluded coronary artery

Sirolimus eluting stentZotarolimus eluting stent

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

AZ Middelheim

Antwerp, Antwerpen, 2020, Belgium

Location

AMC

Amsterdam, Amsterdam, 1105AZ, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Eindhoven, 5602ZA, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1090HM, Netherlands

Location

St Antonius Hospital

Nieuwegein, 3435CM, Netherlands

Location

Related Publications (10)

  • Rahel BM, Suttorp MJ, Laarman GJ, Kiemeneij F, Bal ET, Rensing BJ, Ernst SM, ten Berg JM, Kelder JC, Plokker HW. Primary stenting of occluded native coronary arteries: final results of the Primary Stenting of Occluded Native Coronary Arteries (PRISON) study. Am Heart J. 2004 May;147(5):e22. doi: 10.1016/j.ahj.2003.11.023.

    PMID: 15131557BACKGROUND

  • Suttorp MJ, Mast EG, Plokker HW, Kelder JC, Ernst SM, Bal ET. Primary coronary stenting after successful balloon angioplasty of chronic total occlusions: a single-center experience. Am Heart J. 1998 Feb;135(2 Pt 1):318-22. doi: 10.1016/s0002-8703(98)70099-7.

    PMID: 9489982BACKGROUND

  • Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.

    PMID: 8041413BACKGROUND

  • Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.

    PMID: 8041414BACKGROUND

  • 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

  • Sirnes PA, Golf S, Myreng Y, Molstad P, Emanuelsson H, Albertsson P, Brekke M, Mangschau A, Endresen K, Kjekshus J. Stenting in Chronic Coronary Occlusion (SICCO): a randomized, controlled trial of adding stent implantation after successful angioplasty. J Am Coll Cardiol. 1996 Nov 15;28(6):1444-51. doi: 10.1016/s0735-1097(96)00349-x.

    PMID: 8917256BACKGROUND

  • Suttorp MJ, Laarman GJ, Rahel BM, Kelder JC, Bosschaert MA, Kiemeneij F, Ten Berg JM, Bal ET, Rensing BJ, Eefting FD, Mast EG. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation. 2006 Aug 29;114(9):921-8. doi: 10.1161/CIRCULATIONAHA.106.613588. Epub 2006 Aug 14.

    PMID: 16908768BACKGROUND

  • Kandzari DE, Leon MB, Popma JJ, Fitzgerald PJ, O'Shaughnessy C, Ball MW, Turco M, Applegate RJ, Gurbel PA, Midei MG, Badre SS, Mauri L, Thompson KP, LeNarz LA, Kuntz RE; ENDEAVOR III Investigators. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial. J Am Coll Cardiol. 2006 Dec 19;48(12):2440-7. doi: 10.1016/j.jacc.2006.08.035. Epub 2006 Nov 28.

    PMID: 17174180BACKGROUND

  • Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Munzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006 Aug 22;114(8):798-806. doi: 10.1161/CIRCULATIONAHA.105.591206. Epub 2006 Aug 14.

    PMID: 16908773BACKGROUND

  • Suttorp MJ, Laarman GJ; PRISON III study investigators. A randomized comparison of sirolimus-eluting stent implantation with zotarolimus-eluting stent implantation for the treatment of total coronary occlusions: rationale and design of the PRImary Stenting of Occluded Native coronary arteries III (PRISON III) study. Am Heart J. 2007 Sep;154(3):432-5. doi: 10.1016/j.ahj.2007.04.041.

    PMID: 17719285DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary DiseaseCoronary Stenosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Maarten J. Suttorp, MD, PhD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FESC, FACC

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 30, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2010

Study Completion

June 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

NL(4)BE(1)