Study of the Xience V Everolimus-eluting Stent in Saphenous Vein Graft Lesions

NCT ID: NCT00911976

Last Updated: 2012-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-07-31

Brief Summary

The specific aim of the SOS-Xience V study is to examine the 12-month incidence of binary angiographic in-stent restenosis after implantation of the Xience V stent in aortocoronary saphenous vein bypass graft lesions.

Detailed Description

Implantation of bare metal coronary stents (BMS) is currently the preferred percutaneous treatment for aortocoronary saphenous vein bypass graft (SVG) lesions, but is associated with high risk for in-stent restenosis. Although drug-eluting stents (DES) appear promising, there are limited and conflicting data on their efficacy and safety in SVGs. Our group recently completed and reported the results of the SOS (Stenting Of Saphenous vein grafts) trial that compared a paclitaxel-eluting stent with a similar BMS. There is currently no data on the use of the second generation DES in these challenging lesions. The SOS-Xience V study will examine the effects of the Xience V everolimus-eluting stent in SVG lesions.

The specific aim of SOS-Xience V is to examine the 12-month incidence of binary angiographic in-stent restenosis (defined as a stenosis of > 50% of the minimum lumen diameter of the target segment) after implantation of the Xience V stent in SVG lesions.

The Xience V stent will be implanted in 40 consecutive patients who need stenting of a SVG lesion. Patients will undergo repeat follow-up angiography and intravascular ultrasonography at 12 months and will be followed clinically for 12 months to determine:

1. the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography (primary study endpoint), and

2. intra-stent intimal hyperplasia volume accumulation at 12 months, as measured by intravascular ultrasonography, and (b) 12-month incidence of ischemia-driven target vessel revascularization, stent thrombosis, and target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization) (secondary study endpoints), and (c) percent stent strut coverage by optical coherence tomography

Conditions

Coronary Artery Bypass; Atherosclerosis

Keywords

Coronary artery bypass; Stents; Angioplasty, Transluminal, Percutaneous Coronary; Coronary Restenosis; Everolimus; Saphenous vein grafts

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Xience V

Implantation of the Xience V stent in saphenous vein graft lesions

Group Type: EXPERIMENTAL

Xience V coronary stent

Intervention Type: DEVICE

The Xience V stent will be implanted in aortocoronary saphenous vein bypass graft lesions

Interventions

Xience V coronary stent

The Xience V stent will be implanted in aortocoronary saphenous vein bypass graft lesions

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age > 18 years

2. Need for percutaneous coronary intervention of a 50-99% de novo SVG lesion that is between 2.5 and 4.5 mm in diameter, is ≤ 22 mm in length, and can be treated with implantation of a single stent

3. Use of an embolic protection device during the SVG intervention

4. Able and willing to return for angiographic follow-up after 12 months

5. Agree to participate and provide informed consent

Exclusion Criteria

1. Use of stents other than the Xience V stent

2. Planned non-cardiac surgery within the following 12 months

3. Presentation with an ST-segment elevation acute myocardial infarction

4. Any previous percutaneous treatment of the target lesion (with balloon angioplasty, stent, intravascular brachytherapy etc)

5. Any previous percutaneous treatment of the target vessel (of a lesion different than the target lesion) within the prior 12 months

6. Hemorrhagic diatheses, or refusal to receive blood transfusions

7. Current treatment with warfarin

8. Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy

9. Coexisting conditions that limit life expectancy to less than 12 months

10. Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)

11. Patients allergic to contrast material that can not be adequately premedicated

12. History of an allergic reaction or significant sensitivity to everolimus

13. Documented left ventricular ejection fraction (LVEF) < 25% at most recent evaluation

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

Sponsors

North Texas Veterans Healthcare System

FED

Sponsor Role: lead

Responsible Party

Emmanouil Brilakis

Director, Cardiac Catheterization Laboratories

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emmanouil S Brilakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

North Texas Veterans Healthcare System

Subhash Banerjee, MD

Role: STUDY_DIRECTOR

North Texas Veterans Healthcare System

Locations

VA North Texas Healthcare System

Dallas, Texas, United States

Countries

United States

References

Papayannis AC, Michael TT, Yangirova D, Abdel-Karim AR, Kohlhaas J, Mahmood A, Addo T, Haagen D, Makke L, Roesle M, Rangan B, Banerjee S, Brilakis ES. Optical coherence tomography analysis of the stenting of saphenous vein graft (SOS) Xience V Study: use of the everolimus-eluting stent in saphenous vein graft lesions. J Invasive Cardiol. 2012 Aug;24(8):390-4.

Reference Type: RESULT

PMID: 22865309 (View on PubMed)

Other Identifiers

09-016

Identifier Type: -

Identifier Source: org_study_id