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

Atherosclerosis Clinical Trial

— SOS-Xience V  

Official title:

Prospective Evaluation of the Xience V Everolimus-Eluting Stent In Saphenous Vein Graft Atherosclerosis: The Stenting Of Saphenous Vein Grafts Xience V Angiographic Study (SOS-Xience V)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911976
• Other study ID #: 09-016
• Status: Completed
• Phase: Phase 4
• First received: June 2, 2009
• Last updated: October 25, 2012
• Start date: May 2009
• Est. completion date: July 2011

Study information

• Verified date: October 2012
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Bypass

Intervention

Device:
• Xience V coronary stent
The Xience V stent will be implanted in aortocoronary saphenous vein bypass graft lesions

Locations

Country	Name	City	State
United States	VA North Texas Healthcare System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography		12 months	No
Secondary	intra-stent intimal hyperplasia volume accumulation at 12 months, as measured by intravascular ultrasonography		12 months	No
Secondary	incidence of ischemia-driven target vessel revascularization, stent thrombosis, and target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization)		12 months	Yes
Secondary	Percent stent strut coverage by optical coherence tomography		12 months	Yes