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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT00911976
First received: June 2, 2009
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Bypass
Atherosclerosis
Device: Xience V coronary stent
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intra-stent intimal hyperplasia volume accumulation at 12 months, as measured by intravascular ultrasonography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • incidence of ischemia-driven target vessel revascularization, stent thrombosis, and target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Percent stent strut coverage by optical coherence tomography [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xience V
Implantation of the Xience V stent in saphenous vein graft lesions
Device: Xience V coronary stent
The Xience V stent will be implanted 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911976

Locations
United States, Texas
VA North Texas Healthcare System
Dallas, Texas, United States, 75216
Sponsors and Collaborators
North Texas Veterans Healthcare System
Investigators
Principal Investigator: Emmanouil S Brilakis, MD, PhD North Texas Veterans Healthcare System
Study Director: Subhash Banerjee, MD North Texas Veterans Healthcare System
  More Information

Publications:
Responsible Party: Emmanouil Brilakis, Director, Cardiac Catheterization Laboratories, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT00911976     History of Changes
Other Study ID Numbers: 09-016
Study First Received: June 2, 2009
Last Updated: October 25, 2012
Health Authority: United States: Federal Government

Keywords provided by North Texas Veterans Healthcare System:
Coronary artery bypass
Stents
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Restenosis
Everolimus
Saphenous vein grafts

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 19, 2014