Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
This study is enrolling participants by invitation only.
Sponsor:
Endologix
Collaborator:
Abbott Vascular
Information provided by (Responsible Party):
Endologix
ClinicalTrials.gov Identifier:
NCT01070069
First received: February 16, 2010
Last updated: January 13, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To determine the safety and effectiveness of PEVAR.
| Condition | Intervention | Phase |
|---|---|---|
|
Abdominal Aortic Aneurysm |
Device: PEVAR (ProGlide closure) Device: SEVAR (IntuiTrak) Device: PEVAR (Prostar XL closure) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective, Multicenter, Randomized Controlled Trial of Endovascular Aneurysm Repair Using a Bilateral Percutaneous Approach (PEVAR) vs. Standard Approach (SEVAR) Using the IntuiTrak Endovascular AAA Delivery System and the Prostar XL or Perclose ProGlide Suture-Mediated Closure System |
Resource links provided by NLM:
Further study details as provided by Endologix:
Primary Outcome Measures:
- Treatment success as defined as the composite of procedural technical success, absence of vascular complications, and absence of major adverse events as determined by the independent CEC. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- All serious and non-serious adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Stent graft patency and integrity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Health-related Quality of Life Survey [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Clinical utility measures [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard EVAR (IntuiTrak)
EVAR using standard vascular exposure for access
|
Device: SEVAR (IntuiTrak)
Standard vascular exposure for access prior to EVAR
Other Name: IntuiTrak
|
|
Experimental: PEVAR (ProGlide closure)
Percutaneous EVAR facilitated by the ProGlide closure device
|
Device: PEVAR (ProGlide closure)
Percutaneous EVAR facilitated by the ProGlide closure device
Other Names:
|
|
Experimental: PEVAR (ProstarXL closure)
Percutaneous EVAR facilitated by the Prostar XL closure device
|
Device: PEVAR (Prostar XL closure)
Percutaneous EVAR facilitated by the Prostar XL closure device
Other Names:
|
Detailed Description:
In >30 single center publications, percutaneous EVAR facilitated with the Prostar XL or ProGlide closure has been demonstrated to be feasible. To date, no multicenter, randomized controlled trials of the approach are available. Moreover, although the IntuiTrak System and the closure devices are commercially available in the US as FDA-approved devices, no EVAR device and no closure device is FDA approved for a totally percutaneous EVAR application.
The IntuiTrak System is indicated for the treatment of abdominal aortic aneurysms with aortic necks ranging in size from 18mm to 32mm. The System includes a 19Fr integrated introducer sheath, which is designed to reduce exchanges, and may be particularly important in a percutaneous approach. Moreover, the device is the only currently approved EVAR device with a contralateral percutaneous (9Fr) indication.
Patients with abdominal aortic aneurysm who are suitable candidates for endovascular repair using the IntuiTrak System and who meet the prospectively defined inclusion/exclusion criteria specific to the trial will be randomized to PEVAR or to standard EVAR using vascular exposure access in a ratio of 2:1. Physicians who are established experts in the field of percutaneous EVAR will participate in the trial.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female at least 18 years old
- Informed consent form understood and signed and patient agrees to all follow-up visits
- Abdominal aortic aneurysm (AAA) with maximum diameter ≥5cm, or in the range of 4 to 5cm which has increased by 0.5cm or more in the past six months
- Have a suitable ipsilateral common femoral artery for percutaneous access using a 'Pre-close' technique as detailed in the protocol
- Anatomically eligible for the IntuiTrak System per the FDA-approved indications for use (IFU)
Exclusion Criteria:
- Life expectancy <1 year as judged by the investigator;
- Psychiatric or other condition that may interfere with the study;
- Participating in the enrollment or 30-day follow-up phase of another clinical study;
- Known allergy to any device component;
- Coagulopathy or uncontrolled bleeding disorder;
- Ruptured, leaking, or mycotic aneurysm;
- Serum creatinine (S-Cr) level >1.7 mg/dL;
- Traumatic vascular injury;
- Active systemic or localized groin infection;
- Connective tissue disease (e.g., Marfan's Syndrome);
- Renal transplant patient;
- Recent (within prior three months) cerebrovascular accident or myocardial infarction;
- Planned major intervention or surgery within 30 days following the EVAR procedure;
- Requirement for an arterial conduit at the access site;
- Morbidly obese (BMI≥40);
- Calcification throughout the CFA target area anterior wall or circumferentially or over >50% of the posterior wall;
- Femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm;
- Evidence of prior common femoral artery surgery (e.g., groin incision);
- Prior clip-based vascular closure device placement in either arterial access site;
- Collagen-based vascular closure device placement in either arterial access site within the prior 90 days;
- Femoral artery needle puncture in either arterial access site within the prior 30 days;
- Hematoma at the ipsilateral arterial access site
- Significant scarring at the ipsilateral arterial access site
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070069
Locations
| United States, California | |
| Loma Linda VA Medical Center | |
| Loma Linda, California, United States, 92357 | |
| VA San Diego | |
| San Diego, California, United States, 92161 | |
| United States, Florida | |
| Holy Cross Medical Center | |
| Ft. Lauderdale, Florida, United States | |
| VA Gainesville | |
| Gainesville, Florida, United States, 32608 | |
| VA Miami | |
| Miami, Florida, United States, 33125 | |
| Baptist Cardiac and Vascular Institute | |
| Miami, Florida, United States | |
| United States, Illinois | |
| Mercy Hospital | |
| Chicago, Illinois, United States, 60616 | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Mississippi | |
| Forrest General Hospital | |
| Hattiesburg, Mississippi, United States, 39401 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, North Carolina | |
| Mission Hospital | |
| Asheville, North Carolina, United States, 28801 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| Lake Health | |
| Willoughby, Ohio, United States, 44094 | |
| United States, Oklahoma | |
| Oklahoma Heart Hospital | |
| Oklahoma City, Oklahoma, United States, 93120 | |
| United States, South Dakota | |
| North Central Heart Hospital | |
| Sioux Falls, South Dakota, United States, 57108 | |
| United States, Texas | |
| Dallas VA Medical Center | |
| Dallas, Texas, United States, 75216 | |
| St. Luke's Hospital at Texas Heart Institute | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22903 | |
| Inova Fairfax | |
| Falls Church, Virginia, United States, 22042 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
Endologix
Abbott Vascular
More Information
No publications provided by Endologix
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Endologix |
| ClinicalTrials.gov Identifier: | NCT01070069 History of Changes |
| Other Study ID Numbers: | CP-0001 |
| Study First Received: | February 16, 2010 |
| Last Updated: | January 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endologix:
|
Percutaneous Preclose Endologix Abbott Vascular |
Endovascular PEVAR Stent graft Suture mediated closure devices |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013