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

NCT01310309 | Completed

• 1 other identifier: 07-380 Registry
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 23

Brief Summary

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).

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Artery Stenosis; Coronary Artery Restenosis

Keywords

Stents; Drug-eluting Stent; Angioplasty; Coronary Artery stenosis; Coronary Artery Stent Restenosis; Stent Thrombosis

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of all Death, MI (Q-wave and non Q-wave), and ischemia-driven Target Vessel Revascularization (TVR) .

  Composite endpoints are endpoints made up of a range of statistical parameters.

  12 months

Secondary Outcomes (18)

• Adjudicated stent thrombosis

  30 days

• Revascularizations (TLR/TVR/any revascularization)

  30 days

• Composite endpoint of cardiac death, MI (Q-wave and non Q-wave), and ischemia-driven TLR.

  30 days

• Composite endpoint of all death, MI (Q-wave and non Q-wave), and TVR.

  30 days

• Device success

  At time of index procedure

Study Arms (1)

EXecutive Registry

A prospective controlled registry to analyze the clinical efficacy and safety at mid and long-term follow-up in patients with MVD treated with the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS).

Device: Coronary artery placement of a drug-eluting stent

Interventions

Coronary artery placement of a drug-eluting stent DEVICE

Coronary artery placement of a drug-eluting stent (XIENCE V® EECSS)

EXecutive Registry

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

Patients with Multi-Vessel Coronary Artery Disease (MVD) treated with the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS).

You may qualify if:

• Patient must be at least 18 years of age
• 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
• 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)
• 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)
• Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
• Patient must agree to undergo all protocol-required follow-up examinations.
• 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
• Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy)
• Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
• Target lesion \< or = 28 mm in length by visual estimation
• Target lesions must be in a major artery or its principal branches (diagonal or obtuse marginal) with a visually estimated stenosis of \> or = 50%
• 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

You may not qualify if:

• 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
• Patient has current unstable arrhythmias
• Patient has a known left ventricular ejection fraction (LVEF) \<30%
• Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
• Patient is receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
• Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
• Patient is receiving chronic anticoagulation therapy (e.g. coumadin)
• 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
• Elective surgery is planned within the first 9 months (+/- 14 days) after the procedure that will require discontinuing either aspirin or clopidogrel
• 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)
• Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dl, patient on dialysis)
• Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
• Patient has had a significant GI or urinary bleed within the past six months
• 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)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (23)

A.O. San Giovanni di Dio

Agrigento, Italy

Location

Ospedale Maggiore Bologna

Bologna, Italy

Location

Policlinico S. Orsola - Malpighi

Bologna, Italy

Location

A.O. Cannizzaro

Catania, Italy

Location

A.O. Universitaria Vittorio Emanuele - Ferrarotto - S. Bambino

Catania, Italy

Location

A.O. Università Mater Domini c/o Campus Università Magna Grecia

Catanzaro, Italy

Location

A.O. Universitaria OO.RR Foggia

Foggia, Italy

Location

E.O. Ospedali Galliera

Genova, Italy

Location

A.O. Carlo Poma

Mantova, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Ospedale Loreto Mare

Napoli, Italy

Location

A. O. Sant'Andrea

Roma, Italy

Location

Ospedale Generale Madre Vannini

Roma, Italy

Location

Ospedale Sandro Pertini

Roma, Italy

Location

A.S.O. Molinette San Giovanni Battista di Torino

Torino, Italy

Location

Ospedale Maria Vittoria

Torino, Italy

Location

P.O. San Giovanni Bosco

Torino, Italy

Location

San Giovanni Battista - Ospedale Molinette

Torino, Italy

Location

A.O. Universitaria - Ospedale Riuniti Umberto I - G.M. Lancisi - G. Salesi

Torrette Di Ancona, Italy

Location

Ospedale Civile Maggiore - Università di Verona

Verona, 37142, Italy

Location

Ospedale Civile

Vicenza, Italy

Location

Ospedale Civile di Vigevano

Vigevano, Italy

Location

A.O. Della Provincia di Pavia

Voghera, Italy

Location

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Stenosis; Coronary Restenosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Corrado Vassanelli, MD

  Ospedale Civile Maggiore - Università di Verona

  PRINCIPAL INVESTIGATOR

• Flavio Ribichini, MD

  Ospedale Civile Maggiore - Università di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 8, 2011
• Study Start: September 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: June 1, 2011
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

IT (23)