Clinical trial NCT01516723: Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Coronary Disease
Coronary Stenosis
Keywords: drug-eluting stent
chronic total occlusion
hybrid sirolimus-eluting stent
everolimus-eluting stent
Lead sponsor: R&D Cardiologie
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
First posted: 2012-01-25
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: In-segment late luminal loss at 9 months as assessed by an independent angiographic core lab.
timeFrame: 9 month
Secondary outcomes:
measure: In-stent late luminal loss
timeFrame: 9 month
measure: In-stent and in-segment binary restenosis rate
timeFrame: 9 month
measure: In-stent and in-segment minimal lumen diameter
timeFrame: 9 month
measure: Percentage diameter stenosis
timeFrame: 9 month
measure: A composite of major adverse cardiac events (MACE: death, myocardial infarction and clinically driven target lesion revascularization)
timeFrame: 9 month
measure: Stent thrombosis (acute, <1day; subacute, 1 to 30 days; and late, >30 days)
timeFrame: 30 days
measure: Target vessel failure (cardiac death, MI, clinically driven target vessel revascularisation) up to 5 year of clinical follow-up.
timeFrame: 5 years
measure: % of uncovered stent struts, % of malapposed stent struts, tissue strut thickness (µm), absolute volume (mm³) and % of intimal hyperplasia
timeFrame: 9 month
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: AZ Middelheim
city: Amsterdam
country: Netherlands
facility: AMC
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
Study officials:
affiliation: St. Antonius Hospital
name: Maarten J. Suttorp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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