Sirolimus-Eluting Stents for Chronic Total Coronary Occlusions

NCT00258596 | Completed Phase 3

• 1 other identifier: RDC-2002-01-PRISON II
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Primary intracoronary stent placement after successfully crossing chronic total 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. Whether sirolimus-eluting stents are superior to bare metal stents in CTO is unknown. In this prospective randomized trial, bare metal stent implantation will be compared with sirolimus-eluting stent implantation for the treatment of chronic total coronary occlusions. A total of 200 patients will be followed up for 6, 12, and 24 months with angiographic follow-up at 6 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is the binary angiographic restenosis and reocclusion rate at 6 month follow-up.

Conditions

Coronary Artery Disease; Coronary Disease; Coronary Stenosis

Keywords

drug-eluting stent; chronic total occlusion; sirolimus-eluting stent; zotarolimus-eluting stent; QCA

Outcome Measures

Primary Outcomes (1)

• The binary restenosis rate (defined as restenosis >50% on follow-up angiography) at six-month angiography

Secondary Outcomes (5)

• A composite of: Major adverse cardiac events (death, myocardial infarction, and ischemia driven target lesion revascularization)

• Target vessel failure (defined as a composite of death from cardiac causes, myocardial infarction, and ischemia-driven target-vessel revascularization) at 6 month

• In-stent and in-segment minimal lumen diameter

• Percentage in-stent and in-segment diameter stenosis

• In-stent and in-segment late luminal loss at six months follow-up

Interventions

sirolimus-eluting stent DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Estimated duration of the chronic total coronary occlusion of at least two weeks
• Evidence of ischemia related to the target vessel (signs of ischemia during an abnormal exercise test, defined as ST depression of at least 1.0 mm that is horizontal or down-sloping or up-sloping ST depression of at least 2.0 mm or signs of ischemia found during nuclear imaging with exercise, dobutamine or adenosine).

You may not qualify if:

• The lesion could not be crossed
• The use of heparin, aspirin and clopidogrel was prohibited
• Severe renal failure (creatinine\>250µmol/L)
• Patients were unwilling or unable to complete follow-up.

Sponsors & Collaborators

• R&D Cardiologie: lead
• Cordis US Corp.: collaborator

Study Sites (2)

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1090HM, Netherlands

Location

St Antonius Hospital

Nieuwegein, 3435CM, Netherlands

Location

Related Publications (9)

• 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: 15131557 BACKGROUND

• 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: 9489982 BACKGROUND

• 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: 8041413 BACKGROUND

• 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: 8041414 BACKGROUND

• Rensing BJ, Vos J, Smits PC, Foley DP, van den Brand MJ, van der Giessen WJ, de Feijter PJ, Serruys PW. Coronary restenosis elimination with a sirolimus eluting stent: first European human experience with 6-month angiographic and intravascular ultrasonic follow-up. Eur Heart J. 2001 Nov;22(22):2125-30. doi: 10.1053/euhj.2001.2892.

  PMID: 11686669 BACKGROUND

• 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: 14523139 BACKGROUND

• 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: 8917256 BACKGROUND

• Rahel BM, Laarman GJ, Suttorp MJ; PRISON II study investigators. Primary stenting of occluded native coronary arteries II--rationale and design of the PRISON II study: a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of chronic total coronary occlusions. Am Heart J. 2005 Mar;149(3):e1-3. doi: 10.1016/j.ahj.2004.10.027.

  PMID: 15864219 BACKGROUND

• Rahel BM, Laarman GJ, Kelder JC, Ten Berg JM, Suttorp MJ. Three-year clinical outcome after primary stenting of totally occluded native coronary arteries: a randomized comparison of bare-metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions (Primary Stenting of Totally Occluded Native Coronary Arteries [PRISON] II study). Am Heart J. 2009 Jan;157(1):149-55. doi: 10.1016/j.ahj.2008.08.025. Epub 2008 Nov 6.

  PMID: 19081412 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2005
• First Posted: November 24, 2005
• Study Start: January 1, 2003
• Study Completion: September 1, 2006
• Last Updated: March 6, 2007

Record last verified: 2007-01

Locations

NL (2)