Assessment of Clinical Performance and Costs of the Endeavor Resolute Stent "in Real Life" in Spain.

Coronary Artery Disease Clinical Trial

— REDES  

Official title:

Registro Redes - Evaluación Del Comportamiento clínico y Del Coste Del Stent Coronario Endeavor Resolute de Medtronic "en el Mundo Real" en España

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850213
• Other study ID #: MDT-REDES1.7
• Status: Completed
• Phase: N/A
• First received: February 23, 2009
• Last updated: March 22, 2017
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2012
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Redes registry is set up to document the overall clinical performance and costs of the Endeavor Resolute coronary stent in a "real life" subject population of 450 patients that require a stent in Spain. Primary objectives are the overall cost for patients during initial hospitalization and at 1-year follow-up, as well as the MACE rate at 30 days, 6 months and 12 months post procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is >18 years old

• Subject has agreed to participate in the study by signing the "Patient Informed Consent" and/or has authorized the collection and disclosure of their personal health information by signing the "Patient Data Collection Form".

• There is an indication for a drug-eluting stent and a clinical decision to use Endeavor Resolute in all the lesions found.

• Subject is able and willing to co-operate and to comply with the study protocol and undergo follow-up requirements.

Exclusion Criteria:

• Subject is a childbearing or breastfeeding female.

• Subject has a known hypersensitivity or allergy to acetylsalicylic acid, heparin, clopidogrel, ticlopidine, drugs such as zotarolimus, rapamycin, tacrolimus, sirolimus or other similar drugs, or any other analog or derivative drug, cobalt, chrome, nickel, molybdenum or contrast media.

• Subject has a contraindication to anticoagulants and/or antiplatelets.

• Subject's lesion might prevent proper balloon inflation during angioplasty.

• Primary or rescue angioplasty.

• Subject has one or more drug-eluting stents other than Endeavor Resolute in other lesions.

• Intention for elective treatment with other drug-eluting stent other than Endeavor Resolute.

• Current medical condition is associated with a life expectancy = 12 months.

• Subject is participating in another investigational drug or device study and has not completed the follow-up required for that study at least 30 days prior to signing the consent form in this study. Subject can only be enrolled once in this study.

• Subject has a medical condition preventing follow-up as established in the protocol or limiting participation in this study.

• Subject cannot guarantee follow-up.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Endeavor Resolute Stent
Single implantation

Locations

Country	Name	City	State
Spain	Hospital Juan Canalejo	A Coruna
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital de León	Leon
Spain	Hospital Cínico Universitario de Málaga	Malaga
Spain	Hospital Virgen de la Salud	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall patient cost		During initial hospitalization and at 12 month follow-up
Primary	Number of major adverse cardiac events (MACE)		30 days, 6 months and 1 year
Secondary	Rate of stent thrombosis (according to ARC criteria, defined as definite/confirmed, probable and possible)		12 Months
Secondary	Target Lesion Revascularization (TLR)		12 Months
Secondary	Procedure, device and lesion success rate		30 Days