PITT PCI Xience Registry

NCT01299207 | Completed

• 1 other identifier: 0022189
• Study Type: observational
• Target: 2,506
• Locations: 1 country
• Sites: 1

Brief Summary

Stents are devices utilized to treat cholesterol blockages of the coronary (heart) arteries. The introduction of drug-eluting (coated) stents into clinical practice is regarded as a revolutionary breaktrhough, as it has reduced the incidence of re-narrowing of the arteries after percutaneous coronary interventions are performed. There has been, however, concerns of increased risk for clot formation in the heart arteries of patients treated with drug-eluting stents. Therefore, in order to lower the risk of clot formation, it is recommended that patients receiving these types of stents, be treated with dual antiplatelet therapy (blood thinning medication) for one year. The effect of this strategy, however, on clot formation and bleeding complications when utilizing "newer generation" stents, such as the Xience: Everolimus-eluting Stent, have not been well described. Therefore, the aim of this registry study is to evaluate the risk of adverse cardiovascular events, including mortality, non-fatal myocardial infarction, stent thrombosis, hemorrhagic stroke, and severe bleeding in relation to the timing and discontinuation of dual antiplatelet therapy in patients treated with Xience drug-eluting stents, and compare it to patients that do not discontinue dual antiplatelet therapy.

Conditions

Coronary Artery Disease

Keywords

Stents; Drug-Eluting Stents; Stent Thrombosis; Bleeding; Dual-Antiplatelet Therapy

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events (MACE)

  Combined end-point of all cause mortality, non-fatal myocardial infarction, stent thrombosis, need for repeat revascularization.

  24 months

Secondary Outcomes (1)

• Major Bleeding Events

  24 months

Study Arms (1)

CAD treated with Xience stents

Patients with CAD who undergo successful stenting with the Xience drug-eluting stent will represent the patient population.

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

The study population will consist of all consecutive patients who undergo coronary stenting with the Xience drug-eluting stent in any of the 4 University of Pittsburgh Medical Center's Hospitals (UPMC Presbyterian, UPMC Shadyside, UPMC Mercy, and UPMC Passavant).

You may qualify if:

• Undergoing a coronary stenting procedure with the Xience drug-eluting stent
• Signed informed consent

You may not qualify if:

• Inability to sign informed consent.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Abbott: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Hemorrhage

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oscar C Marroquin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 18, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 7, 2016

Record last verified: 2016-01

Locations

US (1)