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Completed

NCT Number: NCT01516723

Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Middelheim, Antwerp, Antwerpen, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hybrid sirolimus- and everolimus-eluting stents (ORSIRO, XIENCE PRIME)

Device

Recanalization of totally occluded coronary arteries

Other names: Hybrid sirolimus-eluting stents (ORSIRO, Biotronik), Everolimus-eluting stents (XIENCE PRIME, Abbott)

Primary outcomes

  1. In-segment late luminal loss at 9 months as assessed by an independent angiographic core lab.

    Time frame: 9 month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

R&D Cardiologie

Other

Collaborators

  • Biotronik SE & Co. KG

Registry information

Official study 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)

Acronym: PRISON-IV

Important dates

Study start
2012
Primary completion
2016
Study completion
2020
First posted
Jan 25, 2012
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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