Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Clinical Trial

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

NCT: NCT01516723 · COMPLETED

NCT IDNCT01516723
StatusCOMPLETED
Start Date2012-02
Completion2020-12-31
SponsorR&D Cardiologie (OTHER)
First posted
Last updated

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.

Frequently Asked Questions

What is Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions?

Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions is a clinical trial registered under NCT01516723. Current status: COMPLETED.

What is the status of NCT01516723?

The current status of NCT01516723 (Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions) is: COMPLETED.

When did Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions start?

Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions started on 2012-02.

Related Devices

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.