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

Coronary Artery Disease Clinical Trial

— EXecutive  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531011
• Other study ID #: 07-380 RCT
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2007
• Last updated: May 12, 2015
• Start date: September 2007
• Est. completion date: June 2011

Study information

• Verified date: May 2015
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Restenosis
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Restenosis
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Device:
• XIENCE V® Everolimus Eluting Coronary Stent System
Coronary artery placement of a drug-eluting stent
• TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Coronary artery placement of a drug-eluting stent

Locations

Country	Name	City	State
Italy	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	Milano
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	Policlinico San Marco	Zingonia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent Late Loss (LL)	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.	at 270 days	Yes
Secondary	In-stent Binary Restenosis Rate	This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges.	at 9 months	Yes
Secondary	In-segment Binary Restenosis Rate	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.	at 9 months	Yes
Secondary	In-segment Late Loss (LL)	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.	at 9 months	Yes
Secondary	Composite Rate of Cardiac Death, Myocardial Infarction (MI, Both Q-wave and Non Q-wave), and Ischemia-driven Target Lesion Revascularization (TLR) .	This measure is a calculation of the percentage of participants who experience any of the components of this composite measure.	at 30 days	Yes
Secondary	Composite Rate of All Death, MI (Q-wave and Non Q-wave), and Target Vessel Revascularization (TVR).		at 30 days	Yes
Secondary	Lesion Success	defined as attainment of < 30% residual in-stent stenosis (by visual assessment) using any percutaneous method.	at the time of PCI	No
Secondary	Procedural Success	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.	at the time of PCI	Yes
Secondary	Device Success	defined as achievement of a final residual in-stent diameter stenosis of < 30% (visual assessment) using the assigned device only.	at the time of PCI	Yes
Secondary	Adjudicated Stent Thrombosis.		at 30 days	Yes
Secondary	Adjudicated Stent Thrombosis.		9 months	Yes
Secondary	Revascularizations	(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.	at 30 days	Yes
Secondary	Revascularizations	(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.	9 months	Yes
Secondary	Composite Endpoint of Cardiac Death, MI (Q-wave and Non Q-wave), and Ischemia-driven TLR .	ITT	9 months	Yes
Secondary	Composite Endpoint of All Death, MI (Q-wave and Non Q-wave), and TVR.		9 months	Yes
Secondary	In-stent Minimum Lumen Diameter (MLD).		at 9 months.	Yes
Secondary	In-segment Minimum Lumen Diameter (MLD).		at 9 months.	Yes
Secondary	Proximal Minimum Lumen Diameter (MLD).	Proximal refers to the immediate 5 mm outside of the proximal end of the stent.	at 9 months.	Yes
Secondary	Distal Minimum Lumen Diameter (MLD).	Distal refers to the immediate 5 mm outside of the distal end of the stent.	at 9 months.	Yes