RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population

NCT00752128 | Completed Results DMC

• 1 other identifier: IP091
• Study Type: observational
• Target: 2,349
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Cardiovascular Diseases

Keywords

Drug Eluting Stent; Interventional Cardiology; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)

  12 Months

Secondary Outcomes (1)

• Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition

  12 Months

Interventions

Endeavor Resolute Zotarolimus-Eluting Coronary Stent System DEVICE

Stent implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Vascular: lead
• Medtronic Cardiac Rhythm and Heart Failure: collaborator

Study Sites (1)

Heart Center Bad Krozingen

Bad Krozingen, Germany

Location

Related Publications (4)

• 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.

  PMID: 24510638 DERIVED

• 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.

  PMID: 23954063 DERIVED

• 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.

  PMID: 23523454 DERIVED

• 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.

  PMID: 23468513 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

The data collection in this registry was limited to the collection of MACE (death, myocardial infarction (Q- and non-Q-wave), emergent cardiac bypass surgery and TLR) and stent thrombosis events.

Results Point of Contact

• Title: Marianne Wanten
• Organization: Medtronic Bakken Research Center B.V.

marianne.wanten@medtronic.com

+3143356

Study Officials

• Franz-Josef Neumann, MD

  Heart Center Bad Krozingen, Germany

  PRINCIPAL INVESTIGATOR

• Petr Widimský, MD

  University Hospital Kralovské Vinohrady, Czech Republic

  PRINCIPAL INVESTIGATOR

• Jorge A. Belardi, MD

  Instituto Cardiovascular de Buenos Aires, Argentina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: September 15, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2012
• Last Updated: April 25, 2013
• Results First Posted: December 6, 2011

Record last verified: 2013-04

Locations

DE (1)