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

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: NCT01516723
Recruitment Status : Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : March 28, 2017
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Dr. M.J. Suttorp, R&D Cardiologie

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Disease Coronary Stenosis Device: Hybrid sirolimus- and everolimus-eluting stents (ORSIRO, XIENCE PRIME) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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)
Study Start Date : February 2012
Actual Primary Completion Date : February 2016
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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)

Primary Outcome Measures :
  1. In-segment late luminal loss at 9 months as assessed by an independent angiographic core lab. [ Time Frame: 9 month ]

Secondary Outcome Measures :
  1. In-stent late luminal loss [ Time Frame: 9 month ]
  2. In-stent and in-segment binary restenosis rate [ Time Frame: 9 month ]
  3. In-stent and in-segment minimal lumen diameter [ Time Frame: 9 month ]
  4. Percentage diameter stenosis [ Time Frame: 9 month ]
  5. A composite of major adverse cardiac events (MACE: death, myocardial infarction and clinically driven target lesion revascularization) [ Time Frame: 9 month ]
  6. Stent thrombosis (acute, <1day; subacute, 1 to 30 days; and late, >30 days) [ Time Frame: 30 days ]
  7. Target vessel failure (cardiac death, MI, clinically driven target vessel revascularisation) up to 5 year of clinical follow-up. [ Time Frame: 5 years ]
  8. % of uncovered stent struts, % of malapposed stent struts, tissue strut thickness (µm), absolute volume (mm³) and % of intimal hyperplasia [ Time Frame: 9 month ]
    Assessed by optical coherence tomography

Information from the National Library of Medicine

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


  • 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.


  • 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): NCT01516723

AZ Middelheim
Antwerpen, Belgium, 2020
Amsterdam, Netherlands, 1105AZ
Catharina Ziekenhuis
Eindhoven, Netherlands, 5602ZA
St Antonius Hospital
Nieuwegein, Netherlands, 3435CM
Sponsors and Collaborators
R&D Cardiologie
Biotronik SE & Co. KG
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, R&D Cardiologie Identifier: NCT01516723     History of Changes
Other Study ID Numbers: RDC-2011-02
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Keywords provided by Dr. M.J. Suttorp, 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 Stenosis
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents