EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00531011
First received: September 14, 2007
Last updated: May 3, 2013
Last verified: April 2013
  Purpose

The purpose of this two part study is the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific setting of patients with Multi-Vessel Coronary Artery Disease (MVD).


Condition Intervention Phase
Coronary Disease
Coronary Artery Disease
Coronary Artery Stenosis
Coronary Artery Restenosis
Device: XIENCE V® Everolimus Eluting Coronary Stent System
Device: TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EXecutive Randomized Controlled Trial (RCT): XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the Treatment of the Specific Setting of Patients With Multi-vessel Coronary Artery Disease.

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • In-stent Late Loss (LL) [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
    Full Analysis Set (FAS). LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In stent is measured within the confines of the stent edges.


Secondary Outcome Measures:
  • In-stent Binary Restenosis Rate [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]
    This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges.

  • In-segment Binary Restenosis Rate [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]

    This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges

    In-segment is measured within the confines of the stent edges plus within 5 mm on either side of the stent.


  • In-segment Late Loss (LL) [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]
    LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In segment LL is measured within the confines of the stent edges and within 5 mm of those edges.

  • Composite Rate of Cardiac Death, Myocardial Infarction (MI, Both Q-wave and Non Q-wave), and Ischemia-driven Target Lesion Revascularization (TLR) . [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
    This measure is a calculation of the percentage of participants who experience any of the components of this composite measure.

  • Composite Rate of All Death, MI (Q-wave and Non Q-wave), and Target Vessel Revascularization (TVR). [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Lesion Success [ Time Frame: at the time of PCI ] [ Designated as safety issue: No ]
    defined as attainment of < 30% residual in-stent stenosis (by visual assessment) using any percutaneous method.

  • Procedural Success [ Time Frame: at the time of PCI ] [ Designated as safety issue: Yes ]
    defined as: residual in-stent %DS of < 30% using a percutaneous method, without cardiac death, Q-wave MI, non Q-wave MI, or repeat revasc of the target during hospitalization.

  • Device Success [ Time Frame: at the time of PCI ] [ Designated as safety issue: Yes ]
    defined as achievement of a final residual in-stent diameter stenosis of < 30% (visual assessment) using the assigned device only.

  • Adjudicated Stent Thrombosis. [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Stent Thrombosis. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Revascularizations [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
    (TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.

  • Revascularizations [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    (TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.

  • Composite Endpoint of Cardiac Death, MI (Q-wave and Non Q-wave), and Ischemia-driven TLR . [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    ITT

  • Composite Endpoint of All Death, MI (Q-wave and Non Q-wave), and TVR. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • In-stent Minimum Lumen Diameter (MLD). [ Time Frame: at 9 months. ] [ Designated as safety issue: Yes ]
  • In-segment Minimum Lumen Diameter (MLD). [ Time Frame: at 9 months. ] [ Designated as safety issue: Yes ]
  • Proximal Minimum Lumen Diameter (MLD). [ Time Frame: at 9 months. ] [ Designated as safety issue: Yes ]
    Proximal refers to the immediate 5 mm outside of the proximal end of the stent.

  • Distal Minimum Lumen Diameter (MLD). [ Time Frame: at 9 months. ] [ Designated as safety issue: Yes ]
    Distal refers to the immediate 5 mm outside of the distal end of the stent.


Enrollment: 200
Study Start Date: September 2007
Study Completion Date: June 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: XIENCE V
Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
Device: XIENCE V® Everolimus Eluting Coronary Stent System
Coronary artery placement of a drug-eluting stent
Active Comparator: TAXUS® Liberté™
Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Device: TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Coronary artery placement of a drug-eluting stent

Detailed Description:

This is a clinical evaluation of the XIENCE V® everolimus eluting coronary stent system as a revascularization treatment of patients with multi-vessel coronary artery disease (MVD-CAD).

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 consistently lower than the comparator arm of each study.

The post approval EXECUTIVE 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 EXECUTIVE trial.

The study is composed of two parts:

A Registry, outlined in a separate posting and the Randomized Control Trial (RCT) portion of this study, which is as follows:

-A randomized group of patients aimed at assessing the angiographic efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) compared to the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System.

  Eligibility

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

Inclusion Criteria:

  1. Patient must be at least 18 years of age
  2. Patient is 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
  3. Patient has been diagnosed a MVD, as documented by coronary angiography, i.e. presenting a severe stenosis (>50%) amenable to PCI in at least 2 major epicardial vessels or their principal bifurcation branches (diagonal or obtuse marginal)
  4. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram -ECG- consistent with ischemia)
  5. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
  6. Patient must agree to undergo all protocol-required follow-up examinations.

Angiographic Inclusion Criteria

  1. Patients may receive up to 4 planned XIENCE V® EECSS stents, depending on the number of vessels treated and their respective lesion length. When multiple lesions are present in one or more main coronary branches, complete revascularization should be attempted with the implantation of a maximum of 4 planned stents
  2. Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy)
  3. Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
  4. Target lesion < or = 28 mm in length by visual estimation
  5. Target lesions must be in a major artery or its principal branches (diagonal or obtuse marginal) with a visually estimated stenosis of > or = 50%
  6. Two lesions in a single main coronary artery or its branches do not constitute a MVD situation, therefore this type of patient must not be enrolled

Exclusion Criteria:

  1. Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (non-procedural/spontaneous MI, CK-MB > or = to 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure
  2. Patient has current unstable arrhythmias
  3. Patient has a known left ventricular ejection fraction (LVEF) <30%
  4. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
  5. Patient is receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
  6. Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
  7. Patient is receiving chronic anticoagulation therapy (e.g. coumadin)
  8. Patient has a known hypersensitivity or contraindication to aspirin, paclitaxel, either heparin or bivalirudin, clopidogrel or ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated
  9. Elective surgery is planned within the first 9 months (+/- 14 days) after the procedure that will require discontinuing either aspirin or clopidogrel
  10. Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  11. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dl, patient on dialysis)
  12. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  13. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
  14. Patient has had a significant GI or urinary bleed within the past six months
  15. Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)
  16. Patient is already participating in another investigational use device or drug study or has completed the follow-up phase of another study within the last 30 days.

Angiographic Exclusion Criteria

  1. Target lesion meets any of the following criteria:

    • Left main location
    • 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)
    • Heavy calcification
  2. The patient may need more than 4 planned stents. Bailout stents are allowed but must be of the same type as randomization stent.
  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: NCT00531011

Locations
Italy
A.O. San Giovanni di Dio
Agrigento, Italy
Ospedale Maggiore Bologna
Bologna, Italy
Policlinico S. Orsola - Malpighi
Bologna, Italy
A.O. Universitaria Vittorio Emanuele - Ferrarotto - S. Bambino
Catania, Italy
A.O. Cannizzaro
Catania, Italy
A.O. Università Mater Domini c/o Campus Università Magna Grecia
Catanzaro, Italy
A.O. Universitaria OO.RR Foggia
Foggia, Italy
E.O. Ospedali Galliera
Genova, Italy
A.O. Carlo Poma
Mantova, Italy
Centro Cardiologico Monzino
Milano, Italy
Ospedale Loreto Mare
Napoli, Italy
Ospedale Generale Madre Vannini
Roma, Italy
A. O. Sant'Andrea
Roma, Italy
Ospedale Sandro Pertini
Roma, Italy
San Giovanni Battista - Ospedale Molinette
Torino, Italy
P.O. San Giovanni Bosco
Torino, Italy
Ospedale Maria Vittoria
Torino, Italy
A.S.O. Molinette San Giovanni Battista di Torino
Torino, Italy
A.O. Universitaria - Ospedale Riuniti Umberto I - G.M. Lancisi - G. Salesi
Torrette Di Ancona, Italy
Ospedale Civile Maggiore - Università di Verona
Verona, Italy, 37142
Ospedale Civile
Vicenza, Italy
Ospedale Civile di Vigevano
Vigevano, Italy
A.O. Della Provincia di Pavia
Voghera, Italy
Policlinico San Marco
Zingonia, Italy
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Corrado Vassanelli, MD Ospedale Civile Maggiore - Università di Verona
Principal Investigator: Flavio Ribichini, MD Ospedale Civile Maggiore - Università di Verona
  More Information

No publications provided by Abbott Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00531011     History of Changes
Other Study ID Numbers: 07-380 RCT
Study First Received: September 14, 2007
Results First Received: May 16, 2011
Last Updated: May 3, 2013
Health Authority: Italy: Ethics Committee
United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Stents
Drug-eluting Stent
Angioplasty
Coronary Artery stenosis
Coronary Artery Stent Restenosis
Stent Thrombosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Sirolimus
Everolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents

ClinicalTrials.gov processed this record on October 01, 2014