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

NCT ID: NCT01310309

Last Updated: 2012-12-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-06-30

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).

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 sutdy is composed of two parts:

A Randomized Controlled Trial, outlined in a separate posting and the registry portion of this study, which is as follows:

-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).

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Coronary artery placement of a drug-eluting stent

Intervention Type: DEVICE

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

Interventions

Coronary artery placement of a drug-eluting stent

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

Intervention Type: DEVICE

Eligibility 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.

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corrado Vassanelli, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Civile Maggiore - Università di Verona

Flavio Ribichini, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Civile Maggiore - Università di Verona

Locations

A.O. San Giovanni di Dio

Agrigento, , Italy

Ospedale Maggiore Bologna

Bologna, , Italy

Policlinico S. Orsola - Malpighi

Bologna, , Italy

A.O. Cannizzaro

Catania, , Italy

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

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

Milan, , Italy

Ospedale Loreto Mare

Napoli, , Italy

A. O. Sant'Andrea

Roma, , Italy

Ospedale Generale Madre Vannini

Roma, , Italy

Ospedale Sandro Pertini

Roma, , Italy

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

Torino, , Italy

Ospedale Maria Vittoria

Torino, , Italy

P.O. San Giovanni Bosco

Torino, , Italy

San Giovanni Battista - Ospedale Molinette

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

Ospedale Civile

Vicenza, , Italy

Ospedale Civile di Vigevano

Vigevano, , Italy

A.O. Della Provincia di Pavia

Voghera, , Italy

Countries

Italy

Other Identifiers

07-380 Registry

Identifier Type: -

Identifier Source: org_study_id