One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial

EXCC investigators

Research output: Contribution to journalArticlepeer-review

9 Scopus citations


Objective: To report the 1-year clinical outcomes from the GORE EXCLUDER Conformable AAA Endoprosthesis system in the US regulatory trial. Methods: The study is a prospective, multicenter, investigational device exemption clinical trial at 31 US sites with core laboratory assessment of imaging and independent event adjudication. The primary safety (incidence of major adverse events at 30 days) and effectiveness end points (successful aneurysm treatment at 1 year) were assessed in a cohort of patients with abdominal aortic aneurysms (AAAs). Results: We enrolled 80 patients between December 19, 2017, and February, 27, 2019. The mean maximum aortic diameter was 57.7 ± 7.95 mm (range, 42.5-82.7 mm) with an average patient age of 73.5 ± 8.14 years (range, 56-96 years). Overall technical success was 100% (80/80). The mean hospital length stay was 1.2 ± 0.6 days (range, 1-4 days). No primary safety end point events were observed, including no death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, procedural blood loss of more than 1000 mL, or thromboembolic events including limb occlusion or distal emboli. There were no type I or III endoleaks detected on the 1-, 6-, or 12-month follow-up computed tomography scans. There were no stent fractures, device migrations (≥10 mm), AAA ruptures, or conversions to open surgical repair observed. Two patients had AAA sac growth of more than 5 mm at 1 year owing to type II endoleaks. There were no aneurysm-related deaths within the 12-month follow-up, and freedom from aneurysm-related mortality was 100% through 1 year. Conclusions: The safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis system has been demonstrated with 98.5% freedom from primary effectiveness end point events at 1 year and 100% freedom from primary safety end point events assessed through 30 days.

Original languageEnglish (US)
Pages (from-to)951-959.e2
JournalJournal of Vascular Surgery
Issue number4
StatePublished - Oct 2022


  • Abdominal aortic aneurysm
  • Endograft
  • Endovascular repair
  • Endoleak/etiology
  • Prospective Studies
  • United States
  • Humans
  • Middle Aged
  • Endovascular Procedures
  • Treatment Outcome
  • Prosthesis Design
  • Aortic Aneurysm, Abdominal/complications
  • Time Factors
  • Aged, 80 and over
  • Stents/adverse effects
  • Aged
  • Blood Vessel Prosthesis/adverse effects
  • Postoperative Complications
  • Blood Vessel Prosthesis Implantation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery


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