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)

This study has been completed.
Sponsor:
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01171820
First received: April 1, 2010
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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).


Condition Intervention Phase
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Device: TAXUS® Liberté™
Device: XIENCE V® EECSS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • In-stent Late Loss(LL) [ Time Frame: 270 days ] [ Designated as safety issue: No ]
    In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up


Secondary Outcome Measures:
  • Clinical Device Success [ Time Frame: Acute: At time of index procedure ] [ Designated as safety issue: No ]
    Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy.

  • Clinical Procedure Success [ Time Frame: Acute: At time of index procedure ] [ Designated as safety issue: Yes ]
    Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success.

  • In-segment Late Loss [ Time Frame: 270 days ] [ Designated as safety issue: No ]
    In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up

  • Proximal Late Loss [ Time Frame: 270 day ] [ Designated as safety issue: No ]
    Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up

  • Distal Late Loss [ Time Frame: 270 days ] [ Designated as safety issue: No ]
    Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up

  • In-stent Angiographic Binary Restenosis Rate [ Time Frame: 270 days ] [ Designated as safety issue: No ]
    Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per Quantitative Coronary Angiogram.

  • In-segment Angiographic Binary Restenosis Rate [ Time Frame: 270 days ] [ Designated as safety issue: No ]
    Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per Quantitative Coronary Angiogram.

  • In-stent Percent Diameter Stenosis [ Time Frame: 270 days ] [ Designated as safety issue: No ]

    This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.

    This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiogram.


  • In-segment Percent Diameter Stenosis [ Time Frame: 270 days ] [ Designated as safety issue: No ]

    This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.

    This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiogram.


  • Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    A thrombosis is blood clot that forms on the stent. This outcome measures the percentage of participants found to have this condition.

  • Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
    A thrombosis is blood clot that forms on the stent

  • Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    A thrombosis is blood clot that forms on the stent

  • Adjudicated Revascularizations (TLR/TVR/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Revascularizations (TLR/TVR/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Revascularizations (TLR/TVR/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite Rate of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite Rate of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite Rate of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite Rate of All Death, MI and Target Vessel Revascularization (TVR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite Rate of All Death, MI and Target Vessel Revascularization (TVR) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite Rate of All Death, MI and Target Vessel Revascularization (TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite Rate of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite Rate of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) [ Time Frame: 240 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite Rate of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 324
Study Start Date: November 2006
Study Completion Date: July 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TAXUS® Liberté™ Device: TAXUS® Liberté™
Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
Active Comparator: XIENCE V® EECSS Device: XIENCE V® EECSS
Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes

Detailed Description:

The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic sub-study and the Registry.

The SPIRIT V Diabetic sub-study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the XIENCE V® EECSS to the TAXUS® Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected sites.

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Diabetic study after 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 CABG surgery
  • agree to undergo all 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

Exclusion Criteria:

  • known diagnosis of AMI within 72 hours preceding the index procedure
  • current unstable arrhythmias
  • LVEF < 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, WBC limits or documented or suspected liver disease
  • renal insufficiency
  • history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • CVA or TIA 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:

  • In-stent restenotic
  • aorto-ostial location (within 3 mm)
  • left main location
  • located within 2 mm of the origin of the LAD or LCX
  • located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation)
  • lesion involving a side branch ≥ 2.5 mm in diameter
  • lesion involving a side branch with > 50% stenosis by visual estimation Lesion involving a side branch requiring predilatation
  • located in a major epicardial vessel that has been previously treated with brachytherapy
  • located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), < 9 months prior to the index procedure
  • total occlusion (TIMI flow 0), prior to wire crossing
  • excessive tortuosity proximal to or within the lesion
  • extreme angulation (≥ 90%) proximal to or within the lesion
  • heavy calcification

The target vessel contains visible thrombus

Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)

Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171820

Locations
Austria
Salzburger Landeskliniken
Salzburg, Austria
France
C.H.U. - Hopital Michallon
Grenoble, France
CHU Lille - Hôpital Cardiologique
Lille, France
Germany
Herzzentrum
Bernau, Germany
Universitätsklinikum
Heidelberg, Germany
Lukas Krankenhaus Neuss
Neuss, Germany
Herzzentrum Siegburg GmbH
Siegburg, Germany
Israel
Sheba Medical Center
Ramat Gan, Israel
Italy
Azienda Ospedaliera Riuniti
Bergamo, Italy
Ospedale Civile
Mirano, Italy
Azienda Ospedaliera di Padova
Padova, Italy
IRCCS Policlinico San Matteo
Pavia, Italy
Azienda Ospedaliera S. Gdi Dio Salerno
Salerno, Italy
Malaysia
Institute Jantung Negara
Kuala Lumpur, Malaysia
Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Poland
Medical University of Bydgoszcz
Bydgoszcz, Poland
Spain
General De Alicante
Alicante, Spain
Hospital Belvigte de Barcelona
Barcelona, Spain
Hospital Santa Creu I Sant Pau
Barcelona, Spain
Hospital Puerta de Hierro
Madrid, Spain
Clinico San Carlos
Madrid, Spain
La Paz
Madrid, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital General de Valencia
Valencia, Spain
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
United Kingdom
King's College Hospital
London, United Kingdom
Wessex Cardiac Unit
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Eberhard Grube, MD International Heart Center Rhein-Ruhr, Essen, Germany
Principal Investigator: Upendra Kaul, MD Fortis Hospital, New Delhi, India
  More Information

Additional Information:
No publications provided

Responsible Party: Ellen Travis, Abbott Vascular
ClinicalTrials.gov Identifier: NCT01171820     History of Changes
Other Study ID Numbers: 05-369 Diabetic Sub-study
Study First Received: April 1, 2010
Results First Received: August 31, 2010
Last Updated: October 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Abbott Vascular:
drug eluting stents
stents
Angioplasty
coronary artery disease
total coronary occlusion
coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014