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

March 27, 2017 updated by: Dr. M.J. Suttorp, R&D Cardiologie

Hybrid Sirolimus-eluting Stent With Bioresorbable Polymer Versus Everolimus-eluting Stent With Durable Polymer for Total Coronary Occlusions in Native Coronary Arteries (PRISON-IV)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2020
        • Az Middelheim
  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • AMC
      • Eindhoven, Netherlands, 5602ZA
        • Catharina Ziekenhuis
      • Nieuwegein, Netherlands, 3435CM
        • St Antonius Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-segment late luminal loss at 9 months as assessed by an independent angiographic core lab.
Time Frame: 9 month
9 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent thrombosis (acute, <1day; subacute, 1 to 30 days; and late, >30 days)
Time Frame: 30 days
30 days
In-stent late luminal loss
Time Frame: 9 month
9 month
In-stent and in-segment binary restenosis rate
Time Frame: 9 month
9 month
In-stent and in-segment minimal lumen diameter
Time Frame: 9 month
9 month
Percentage diameter stenosis
Time Frame: 9 month
9 month
A composite of major adverse cardiac events (MACE: death, myocardial infarction and clinically driven target lesion revascularization)
Time Frame: 9 month
9 month
Target vessel failure (cardiac death, MI, clinically driven target vessel revascularisation) up to 5 year of clinical follow-up.
Time Frame: 5 years
5 years
% 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
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R&D Cardiologie

Collaborators

Biotronik SE & Co. KG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

November 15, 2011

First Submitted That Met QC Criteria

January 24, 2012

First Posted (ESTIMATE)

January 25, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDC-2011-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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