Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions (PRISON-IV)

This study is currently recruiting participants.
Verified March 2012 by R&D Cardiologie
Sponsor:
Collaborator:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Dr. M.J. Suttorp, R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT01516723
First received: November 15, 2011
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

Percutaneous recanalization of total coronary occlusions (TCO) was historically hampered by high rates of restenosis and reocclusion. In the PRISON II and III trial we showed landmark reduction in restenosis with sirolimus-eluting stents (Cypher, Cordis Corporation) compared to conventional bare metal stents in TCO. In the PRISON III trial, we observed similar favourable results with second-generation zotarolimus-eluting stent (Resolute, Medtronic Inc.). Another drugs-eluting stent mounted with everolimus (Xience Prime, Abbott) also demonstrated favourable results in TCO. Recently, drug-eluting stents (DES) with bioresorbable polymer coatings were developed, to address safety concerns regarding the observation of very late stent thrombosis, due to hypersensitivity reactions, and chronic inflammation, on the durable polymer coating of DES. However, none of these DES with bioresorbable polymers were evaluated in patients with TCO. The PRISON IV trial is a prospective, randomized, single-blinded, multi-center trial, designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (ORSIRO, Biotronik Inc.) compared to everolimus-eluting stents with durable polymers (Xience Prime, Abbott) in patients with successfully recanalized TCOs.


Condition Intervention Phase
Coronary Artery Disease
Coronary Disease
Coronary Stenosis
Device: Hybrid sirolimus- and everolimus-eluting stents (ORSIRO, XIENCE PRIME)
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: Hybrid Sirolimus-eluting Stent With Bioresorbable Polymer Versus Everolimus-eluting Stent With Durable Polymer for Total Coronary Occlusions in Native Coronary Arteries (PRISON-IV)

Resource links provided by NLM:


Further study details as provided by R&D Cardiologie:

Primary Outcome Measures:
  • In-segment late luminal loss at 9 months as assessed by an independent angiographic core lab. [ Time Frame: 9 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In-stent late luminal loss [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  • In-stent and in-segment binary restenosis rate [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  • In-stent and in-segment minimal lumen diameter [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  • Percentage diameter stenosis [ Time Frame: 9 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: 9 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 (cardiac death, MI, clinically driven target vessel revascularisation) up to 5 year of clinical follow-up. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • % of uncovered stent struts, % of malapposed stent struts, tissue strut thickness (µm), absolute volume (mm³) and % of intimal hyperplasia [ Time Frame: 9 month ] [ Designated as safety issue: No ]
    Assessed by optical coherence tomography


Estimated Enrollment: 330
Study Start Date: February 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hybrid sirolimus-eluting stents
ORSIRO, Biotronik Inc.
Device: Hybrid sirolimus- and everolimus-eluting stents (ORSIRO, XIENCE PRIME)
Recanalization of totally occluded coronary arteries
Other Names:
  • Hybrid sirolimus-eluting stents (ORSIRO, Biotronik)
  • Everolimus-eluting stents (XIENCE PRIME, Abbott)
Active Comparator: Everolimus-eluting stents
XIENCE PRIME, Abbott
Device: Hybrid sirolimus- and everolimus-eluting stents (ORSIRO, XIENCE PRIME)
Recanalization of totally occluded coronary arteries
Other Names:
  • Hybrid sirolimus-eluting stents (ORSIRO, Biotronik)
  • Everolimus-eluting stents (XIENCE PRIME, Abbott)

Detailed Description:

A total of 330 patients are randomized to either hybrid sirolimus-eluting stent or everolimus-eluting stent after successful recanalization of TCO. Clinical follow-up at 1, 6, 12 months, 2, 3, 4, 5 year with angiographic follow-up at 9 months. In 60 patients a optical coherence tomography is performed during the 9 months follow-up angiography. Quantitative coronary and optical coherence tomography analysis is performed by two independent core laboratory. The primary end point is in-segment late luminal loss at 9 month angiographic follow-up. Secondary angiographic end points include the following; in-stent luminal loss, acute recoil, acute gain, net luminal gain, late loss index, minimal lumen diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9 months angiographic follow-up. Secondary clinical endpoints include a composite of major adverse cardiac events (death, MI and clinically driven target lesion revascularization); clinically driven target vessel revascularisation (TVR), target vessel failure (cardiac death, MI, clinically driven TVR) and stent thrombosis up to 5 year clinical follow-up. Tertiary optical coherence tomography end points at 9 months follow-up are the following: Percentage of uncovered stent struts, percentage of malapposed stent struts, tissue strut thickness, absolute and percentage of intimal hyperplasia.

  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 4 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516723

Contacts
Contact: Maarten J. Suttorp, MD, PhD 31-30-6099111 ext 238 m.suttorp@antonius.net
Contact: Mike AR Bosschaert, MD 31-30-6092278 m.bosschaert@antonius.net

Locations
Belgium
AZ Middelheim Not yet recruiting
Antwerpen, Belgium, 2020
Contact: G. Langenhove, PhD    +32-32803255    glenn.vanlangenhove@zna.be   
Principal Investigator: G. Langenhove, PhD         
Netherlands
AMC Not yet recruiting
Amsterdam, Netherlands, 1105AZ
Contact: J. P. Henriques, PhD    +31-20-5669111    j.p.henriques@amc.uva.nl   
Principal Investigator: J. P. Henriques, PhD         
Catharina Ziekenhuis Not yet recruiting
Eindhoven, Netherlands, 5602ZA
Contact: J. J. Koolen, PhD    +31-40-2397004    jacques.koolen@cze.nl   
Principal Investigator: J. J. Koolen, PhD         
St Antonius Hospital Recruiting
Nieuwegein, Netherlands, 3435CM
Contact: Maarten J. Suttorp, MD, PhD    31-306099111 ext 238    m.suttorp@antonius.net   
Contact: Mike AR Bosschaert, MD    31-30602278    m.bosschaert@antonius.net   
Principal Investigator: Maarten J. Suttorp, MD, PhD         
Sponsors and Collaborators
R&D Cardiologie
Biotronik SE & Co. KG
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, R&D Cardiologie
ClinicalTrials.gov Identifier: NCT01516723     History of Changes
Other Study ID Numbers: RDC-2011-02
Study First Received: November 15, 2011
Last Updated: March 19, 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
hybrid sirolimus-eluting stent
everolimus-eluting stent

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
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014