Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions (PRISON-IV)
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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) |
- 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 ]
- 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:
|
|
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:
|
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 |
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| 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 |
| 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 | |
| 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 May 16, 2013