SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)

NCT01171820 | Completed Phase 4 Results DMC

• 1 other identifier: 05-369 Diabetic Sub-study
• Study Type: interventional
• Target: 324
• Locations: 11 countries
• Sites: 28

Brief Summary

The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Keywords

drug eluting stents; stents; Angioplasty; coronary artery disease; total coronary occlusion; coronary artery restenosis; stent thrombosis; vascular disease; myocardial ischemia; coronary artery stenosis

Outcome Measures

Primary Outcomes (1)

• In-stent Late Loss (LL)

  In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up

  270 days

Secondary Outcomes (24)

• Clinical Device Success (Per-lesion)

  immediately post-procedure

• Clinical Procedure Success (Per-patient)

  immediately post-procedure

• In-segment Late Loss

  270 days

• Proximal Late Loss

  270 day

• Distal Late Loss

  270 days

Study Arms (2)

TAXUS® Liberté™

ACTIVE COMPARATOR

Device: TAXUS® Liberté™

XIENCE V® EECSS

ACTIVE COMPARATOR

Device: XIENCE V® EECSS

Interventions

TAXUS® Liberté™ DEVICE

Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes

TAXUS® Liberté™

XIENCE V® EECSS DEVICE

Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes

XIENCE V® EECSS

Eligibility Criteria

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

You may qualify if:

• at least 18 years
• able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
• diagnosed with diabetes, as documented by medical history.
• evidence of myocardial ischemia
• acceptable candidate for coronary artery bypass grafting (CABG) surgery
• agree to undergo all clinical investigation plan (CIP)-required follow-up examinations
• artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
• maximum of one, de novo, target lesion per native major epicardial vessel or side branch
• target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
• target lesion ≤ 28 mm in length by visual estimate
• target lesion must be in a major artery or branch with a visually estimated stenosis of \> 50% and \< 100% and a TIMI flow \> 1

You may not qualify if:

• known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure
• current unstable arrhythmias
• Left ventricular ejection fraction \< 30%
• received a heart or any other organ transplant or is on a waiting list for any organ transplant
• receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
• receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease
• known hypersensitivity or contraindication to specific agents
• elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel
• platelet count limits, white blood cell limits or documented or suspected liver disease
• renal insufficiency
• history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Cerebrovascular accident or transient ischemic attack within the past 6 months
• significant GI or urinary bleed within the past 6 months
• history of other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)
• Target lesion meets any of the following criteria:

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (28)

Salzburger Landeskliniken

Salzburg, Austria

Location

C.H.U. - Hopital Michallon

Grenoble, France

Location

CHU Lille - Hôpital Cardiologique

Lille, France

Location

Herzzentrum

Bernau, Germany

Location

Universitätsklinikum

Heidelberg, Germany

Location

Lukas Krankenhaus Neuss

Neuss, Germany

Location

Herzzentrum Siegburg GmbH

Siegburg, Germany

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Azienda Ospedaliera Riuniti

Bergamo, Italy

Location

Ospedale Civile

Mirano, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

IRCCS Policlinico San Matteo

Pavia, Italy

Location

Azienda Ospedaliera S. Gdi Dio Salerno

Salerno, Italy

Location

Institute Jantung Negara

Kuala Lumpur, Malaysia

Location

Medisch Centrum Alkmaar

Alkmaar, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

Medical University of Bydgoszcz

Bydgoszcz, Poland

Location

General De Alicante

Alicante, Spain

Location

Hospital Belvigte de Barcelona

Barcelona, Spain

Location

Hospital Santa Creu I Sant Pau

Barcelona, Spain

Location

Clinico San Carlos

Madrid, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

La Paz

Madrid, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Spain

Location

Hospital General de Valencia

Valencia, Spain

Location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

Wessex Cardiac Unit

Southampton, Southampton, SO16 6YD, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Related Links

• SPIRIT V registry arm

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Robert Smith Jr, Ph.D., Sr Clinical Research Scientist
• Organization: Abbott Vascular

robert.smithjr@av.abbott.com

408-845-8265

Study Officials

• Eberhard Grube, MD

  International Heart Center Rhein-Ruhr, Essen, Germany

  PRINCIPAL INVESTIGATOR

• Upendra Kaul, MD

  Fortis Hospital, New Delhi, India

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: July 29, 2010
• Study Start: November 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2010
• Last Updated: June 27, 2016
• Results First Posted: October 21, 2010

Record last verified: 2016-06

Locations

DE (4); MY (1); TH (1); ES (8); NL (2); PL (1); IT (5); AU (1); IL (1); FR (2); GB (2)