Coronary Artery DiseaseR-IntNCT00752128

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

An observational study of Coronary Artery Disease and Cardiovascular Diseases, run by Medtronic Vascular at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Cardiovascular Diseases
What is being tested?: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System
Type of treatment: Medical device
How many people: 2,349 participants
Where: 1 siteGermany
Study dates: Aug 2008to Dec 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Heart Center Bad Krozingen
Bad Krozingen

Other trials in Germany

About this study

Read the 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.

Conditions: Coronary Artery Disease, Cardiovascular Diseases
Being tested: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System
Keywords: Drug Eluting Stent, Interventional Cardiology, Percutaneous Coronary Intervention
Medical subject headings: Coronary Artery Disease, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endeavor Resolute Zotarolimus-Eluting Coronary Stent SystemDevice
Stent implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)
Measured: 12 Months

Secondary outcomes (1)

Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Dec 2012

First posted15 Sep 2008 (estimated)
Study startAug 2008
Primary completionOct 2010
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,349 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00752128
Sponsor's protocol ID: IP091
Acronym: R-Int
Status last verified: Apr 2013
First submitted: 12 Sep 2008
Last updated: 25 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 24510638
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.
PubMed 23954063
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.
PubMed 23523454
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.
PubMed 23468513

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population
ClinicalTrials.gov ID: NCT00752128
Acronym / sponsor ID: R-Int / IP091
Conditions: Coronary Artery Disease, Cardiovascular Diseases
Keywords: Drug Eluting Stent, Interventional Cardiology, Percutaneous Coronary Intervention
Study type: Observational
Recruitment status: Completed
Enrolment: 2,349 participants (actual)
Lead sponsor: Medtronic VascularIndustry (pharma, biotech, devices)
Collaborators: Medtronic Cardiac Rhythm and Heart Failure
Study start: Aug 2008
Primary completion: Oct 2010 (actual)
Study completion: Dec 2012 (actual)
First posted: 15 Sep 2008 (estimated)
Results: Posted 6 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Endeavor Resolute Zotarolimus-Eluting Coronary Stent SystemStent implantation	Device	–

Primary outcome

Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)
Time frame: 12 Months

1 secondary outcome

Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition
Time frame: 12 Months

Results and safety

Results posted to the registry on 6 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Resolute Drug-Eluting Stent	2,349	2,345

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

Time frame: 12 Months. Number. Unit: percentage of participants

Measure	Cardiac Death or Target Vessel MI n = 2334
Value	4.2

Population analysed: Analysis per intention to treat

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Resolute Drug-Eluting Stent	33 of 2,334 (1.4%)	0 of 2,334 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24510638Silber 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.
Derived from this study: PubMed 23954063Richardt 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.
Derived from this study: PubMed 23523454Silber 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.
Derived from this study: PubMed 23468513Farooq 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Franz-Josef Neumann, MD principal investigator

Heart Center Bad Krozingen, Germany

Petr Widimský, MD principal investigator

University Hospital Kralovské Vinohrady, Czech Republic

Jorge A. Belardi, MD principal investigator

Instituto Cardiovascular de Buenos Aires, Argentina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Cardiovascular Diseases, run by Medtronic Vascular at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel) (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00752128, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2013.