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The Boston Scientific ENOVUS Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00246038
Recruitment Status : Withdrawn (Sponsor cancelled the development program, and never conducted the study.)
First Posted : October 30, 2005
Last Update Posted : August 31, 2015
Sponsor:
Information provided by:
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE October 27, 2005
First Posted Date  ICMJE October 30, 2005
Last Update Posted Date August 31, 2015
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2015)
Efficacy will evaluate patients (Treatment Group) free from AAA rupture and surgical conversion within 1 year of the initial procedure.
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2005)
  • The safety of the Boston Scientific ENOVUS AAA Endograft will be determined by comparing the rate of major morbidity in the Treatment Group against the rate of major morbidity in the Control Group within 30 days of the initial procedure.
  • The efficacy of the Boston Scientific ENOVUS AAA Endograft will be determined by evaluating the proportion of patients in the Treatment Group that are free from AAA rupture and conversion to open surgical repair within 1 year of the initial procedure.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2005)
  • The secondary safety endpoints will be compared between the Treatment and Control Groups:
  • • Mortality rates at 30 days and 1 year
  • • AAA related mortality at 30 days and 1 year
  • The secondary efficacy endpoints will be evaluated in the Treatment Group only and include:
  • Technical success, enlargement of AAA, migration, significant endoleak, and loss of device integrity.
  • Secondary Clinical Utility endpoints will be compared between the Treatment and Control groups and will include: blood loss, duration of procedure, ICU stay, length of hospital stay, and duration of anesthesia.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Boston Scientific ENOVUS Trial
Official Title  ICMJE A Phase II Evaluation of the Safety and Efficacy of the Boston Scientific ENOVUS AAA Endograft in the Treatment of Abdominal Aortic Aneurysms
Brief Summary A prospective, actively controlled, consecutively enrolling, non-randomized multi center clinical evaluation of the safety and efficacy of the Boston Scientific ENOVUS AAA Endograft when used in the treatment of patients with AAA (Treatment Group) as compared to patients treated with conventional open surgery (Control Group).
Detailed Description

The primary objectives of this study are to determine whether the Boston Scientific ENOVUS AAA Endograft is a safe and effective method of treating AAA's in those patients considered to be suitable candidates for open surgical repair. The safety of the Boston Scientific ENOVUS AAA Endograft will be determined by comparing the rate of major morbidity in the Treatment Group against the rate of major morbidity in the Control Group within 30 days of the initial procedure. The efficacy of the Boston Scientific ENOVUS AAA Endograft will be determined by evaluating the proportion of patients in the Treatment Group that are free from AAA rupture and conversion to open surgical repair within 1 year of the initial procedure.

The secondary safety endpoints will be compared between the Treatment and Control Groups:Mortality rates at 30 days and 1 year, AAA related mortality at 30 days and 1 year. The secondary efficacy endpoints will be evaluated in the Treatment Group only and include: Technical success, enlargement of AAA, migration, significant endoleak, and loss of device integrity. Secondary Clinical Utility endpoints will be compared between the Treatment and Control groups and will include: blood loss, duration of procedure, ICU stay, length of hospital stay, and duration of anesthesia.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Abdominal Aortic Aneurysm
Intervention  ICMJE Device: Boston Scientific ENOVUS AAA Endograft
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 27, 2015)
0
Original Enrollment  ICMJE
 (submitted: October 27, 2005)
307
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:

    1. Patient is > 18 years of age
    2. Females of childbearing potential have a negative pregnancy test at the time of treatment
    3. Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form
    4. Patient is considered by the treating physician to be a candidate (i.e., categories I, II, or III) for elective open surgical repair of the AAA per American Society of Anesthesiology (ASA) refer to Appendix II. ASA grade IV patients may be enrolled provided their life expectancy is greater than 1 year.
    5. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:•Abdominal aortic aneurysm >4.5 cm in diameter

      • Aneurysm has increased in size by 0.5 cm in last 6 months.
      • Maximum diameter of aneurysm exceeds one and one-half times the transverse dimension of an adjacent normal aortic segment
    6. Patient must be willing to comply with all required follow-up exams (open surgical control patients are followed through one year, Treatment Group patients are followed through five years in the study with lifelong follow up by physician thereafter).

Exclusion Criteria:

  • Patients that meet ANY of the following are not eligible for enrollment into the study:

    1. Aneurysm dissection
    2. Acutely ruptured aneurysm
    3. Acute vascular injury
    4. Need for emergent surgery
    5. Patient has a known thoracic aortic aneurysm or dissection.
    6. Patient has unstable angina (defined as angina characterized by progressive increase in anginal symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
    7. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
    8. Patient has history of bleeding disorders or refuses blood transfusions.
    9. Patient has baseline serum creatinine level >2.0 mg/dl
    10. Patient has a known hypersensitivity or contraindication to anticoagulation that is not amenable to pre-treatment.
    11. Patient has a mycotic aneurysm or has an active systemic infection
    12. Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta
    13. Patient has a limited life expectancy of less than 1 year
    14. Patient is currently participating in another investigational device or drug clinical trial
    15. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving this treatment, pre-treatment, and post-treatment procedures and evaluations.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00246038
Other Study ID Numbers  ICMJE 810-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pamela Grady, PhD, Director, Clinical Programs, Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodney A. White, MD; Chief, Vascular Surgery University of California, Los Angeles
Principal Investigator: W. Anthony Lee, MD; Assistant Professor of Surgery University of Florida
PRS Account Boston Scientific Corporation
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP