Clinical trial NCT00752128: RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population
Official title: RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Cardiovascular Diseases
Keywords: Drug Eluting Stent
Interventional Cardiology
Percutaneous Coronary Intervention
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic Cardiac Rhythm and Heart Failure
First posted: 2008-09-15
Enrollment: 2349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients eligible for drug-eluting stent implantation with the elective use of the Endeavor Resolute stent in one or more target lesions are candidates to be enrolled

Brief summary: The primary objective of the RESOLUTE international registry is to document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a 'real-world' patient population requiring stent implantation.

Detailed description: As part of the broader clinical program of the Resolute stent, the RESOLUTE International registry will expand the experience and understanding of the device performance in a 'real-world' setting. The registry intends to enroll patients from a large number of centers under commercial usage conditions, with the aim to reflect 'real-world' usage as much as possible.

Eligibility criteria: Inclusion Criteria:

* Minimum legal age (18)
* Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines
* Patient has consented to participate and authorized in writing the collection and release of medical information
* Elective use of the Endeavor Resolute stent

Exclusion Criteria:

* Pregnancy
* High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
* Currently participating in another trial preventing routine hospital treatment
* Previous enrollment in the RESOLUTE International registry

Primary outcomes:
measure: Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)
timeFrame: 12 Months
Secondary outcomes:
measure: Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition
timeFrame: 12 Months
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Heart Center Bad Krozingen
Study officials:
affiliation: Heart Center Bad Krozingen, Germany
name: Franz-Josef Neumann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Kralovské Vinohrady, Czech Republic
name: Petr Widimský, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Cardiovascular de Buenos Aires, Argentina
name: Jorge A. Belardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silber S, Kirtane AJ, Belardi JA, Liu M, Brar S, Rothman M, Windecker S. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. 2014 Aug 1;35(29):1949-56. doi: 10.1093/eurheartj/ehu026. Epub 2014 Feb 7.
citation: Richardt G, Leschke M, Abdel-Wahab M, Toelg R, El-Mawardy M, Serruys PW, Silber S, Windecker S, Belardi JA, Neumann FJ, Widimsky P; RESOLUTE All Comers; RESOLUTE International Investigators. Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis. JACC Cardiovasc Interv. 2013 Sep;6(9):905-13. doi: 10.1016/j.jcin.2013.04.017. Epub 2013 Aug 14.
citation: Silber S, Serruys PW, Leon MB, Meredith IT, Windecker S, Neumann FJ, Belardi J, Widimsky P, Massaro J, Novack V, Yeung AC, Saito S, Mauri L. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv. 2013 Apr;6(4):357-68. doi: 10.1016/j.jcin.2012.11.006. Epub 2013 Mar 20.
citation: Farooq V, Vranckx P, Mauri L, Cutlip DE, Belardi J, Silber S, Widimsky P, Leon M, Windecker S, Meredith I, Negoita M, van Leeuwen F, Neumann FJ, Yeung AC, Garcia-Garcia HM, Serruys PW. Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program. Heart. 2013 May;99(9):626-33. doi: 10.1136/heartjnl-2012-303368. Epub 2013 Mar 6.