XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)

NCT00676520 | Completed Results DMC

• 1 other identifier: 06-374
• Study Type: observational
• Target: 8,053
• Locations: 1 country
• Sites: 1

Brief Summary

XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are

• To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and
• To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.

Conditions

Coronary Artery Disease

Keywords

Angioplasty; Coronary Restenosis; Coronary Artery Disease; Coronary Artery Restenosis; Coronary Artery Stenosis; Total Artery Occlusion; Stents; Stent Thrombosis; Total Coronary Occlusion; Vascular Disease; Myocardial Ischemia

Outcome Measures

Primary Outcomes (2)

• Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium).

  ARC Defines Stent Thrombosis in the following way: Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria: Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause Possible Stent Thrombosis Any unexplained death beyond 30 days For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1

  up to 1 year

• Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)

  MI= ARC (Academic Research Constortium) defined

  1 year

Secondary Outcomes (40)

• Clinical Device Success

  acute: post index procedure until hospital discharge

• Procedural Success

  acute: post index procedure until hospital discharge

• Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)

  at 30 days

• Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)

  at 180 days

• Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)

  at 30 days

Study Arms (1)

1

Single-arm study

Device: XIENCE V® Everolimus Eluting Coronary Stent

Interventions

XIENCE V® Everolimus Eluting Coronary Stent DEVICE

Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who agree to participate by signing the Institutional Review Board (IRB) approved informed consent form, and who recieve only XIENCE V® EECSS during the index procedure.

You may qualify if:

• The patient agrees to participate in this study by signing the Institutional Review Board approved informed consent form.

You may not qualify if:

• The inability to obtain an informed consent.
• Age limit is determined by investigator.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

Related Publications (5)

• Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.

  PMID: 25940520 DERIVED

• Sudhir K, Hermiller JB, Naidu SS, Henry TD, Mao VW, Zhao W, Ferguson JM, Wang J, Jonnavithula L, Simonton CA, Rutledge DR, Krucoff MW; XIENCE V USA Investigators. Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V(R) everolimus-eluting stents: one-year results from the XIENCE V USA study. Catheter Cardiovasc Interv. 2013 Oct 1;82(4):E385-94. doi: 10.1002/ccd.24749. Epub 2013 Mar 28.

  PMID: 23172848 DERIVED

• Hermiller JB, Rutledge DR, Gruberg L, Katopodis JN, Lombardi W, Mao VW, Zhao W, Sharma SK, Tamboli HP, Wang J, Jonnavithula L, Sudhir K, Krucoff MW. Sustained low clinical event rates in real-world patients receiving everolimus-eluting coronary stent system from a large, prospective, condition of approval study: 2-year clinical outcomes from the XIENCE V USA Study. J Interv Cardiol. 2012 Dec;25(6):565-75. doi: 10.1111/j.1540-8183.2012.00766.x. Epub 2012 Sep 23.

  PMID: 22998355 DERIVED

• Naidu SS, Krucoff MW, Rutledge DR, Mao VW, Zhao W, Zheng Q, Wilburn O, Sudhir K, Simonton C, Hermiller JB. Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: results from the 8,061-patient XIENCE V United States study. JACC Cardiovasc Interv. 2012 Jun;5(6):626-35. doi: 10.1016/j.jcin.2012.02.014.

  PMID: 22721657 DERIVED

• Krucoff MW, Rutledge DR, Gruberg L, Jonnavithula L, Katopodis JN, Lombardi W, Mao VW, Sharma SK, Simonton CA, Tamboli HP, Wang J, Wilburn O, Zhao W, Sudhir K, Hermiller JB. A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study). JACC Cardiovasc Interv. 2011 Dec;4(12):1298-309. doi: 10.1016/j.jcin.2011.08.010.

  PMID: 22192371 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Vascular Diseases; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Ellen Travis
• Organization: Abbott Vascular

Ellen.Travis@av.abbott.com

408-845-3000

Study Officials

• James Hermiller, MD

  Heart Center of Indianapolis

  PRINCIPAL INVESTIGATOR

• Mitch Krucoff, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• 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: October 16, 2007
• First Posted: May 13, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 20, 2012
• Results First Posted: November 20, 2012

Record last verified: 2012-10

Locations

US (1)