The Boston Scientific ENOVUS Trial

NCT00246038 | Withdrawn Phase 2

• 1 other identifier: 810-0001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm; Aortic Aneurysm; AAA; Endovascular; Stent Graft; Endograft; Vascular Prostheses

Outcome Measures

Primary Outcomes (1)

• Efficacy will evaluate patients (Treatment Group) free from AAA rupture and surgical conversion within 1 year of the initial procedure.

Interventions

Boston Scientific ENOVUS AAA Endograft DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is \> 18 years of age
• Females of childbearing potential have a negative pregnancy test at the time of treatment
• Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form
• 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.
• 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
• 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).

You may not qualify if:

• Patients that meet ANY of the following are not eligible for enrollment into the study:
• Aneurysm dissection
• Acutely ruptured aneurysm
• Acute vascular injury
• Need for emergent surgery
• Patient has a known thoracic aortic aneurysm or dissection.
• 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)
• Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
• Patient has history of bleeding disorders or refuses blood transfusions.
• Patient has baseline serum creatinine level \>2.0 mg/dl
• Patient has a known hypersensitivity or contraindication to anticoagulation that is not amenable to pre-treatment.
• Patient has a mycotic aneurysm or has an active systemic infection
• Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta
• Patient has a limited life expectancy of less than 1 year
• Patient is currently participating in another investigational device or drug clinical trial

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 27, 2005
• First Posted: October 31, 2005
• Last Updated: August 31, 2015

Record last verified: 2015-08