Clinical Study of Aneurysm Exclusion (EndoMed)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Arizona Heart Institute.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Arizona Heart Institute
Information provided by:
Arizona Heart Institute
ClinicalTrials.gov Identifier:
NCT00549016
First received: October 24, 2007
Last updated: May 14, 2009
Last verified: May 2009
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Purpose
The ultimate purpose is to explore the potential techniques to exclude aneurysms and provide an alternative conduit for arterial flow. The single center sponsorship is intended to provide the investigators the potential to incorporate improvements in existing technology during the course of the study thereby ultimately enhancing the potential for superior medical care of patients suffering from these disease states. The sponsor/investigator recognizes and accepts responsibility to notify and receive approval from the agency when device modifications are made that may affect patient safety.
| Condition | Intervention |
|---|---|
|
Aneurysm |
Device: PTPE Encapsulation of Nitinol Stents |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Study of Aneurysm Exclusion Using PTFE Encapsulation of Nitinol Stents |
Resource links provided by NLM:
Further study details as provided by Arizona Heart Institute:
Primary Outcome Measures:
- Technical success in the deployment and placement of the endoluminal graft to the aneurysmal site. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Acute success when the endoluminal graft excludes the aneurysm and maintain patency without endoleaks, migration or rupture. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2002 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Device: PTPE Encapsulation of Nitinol Stents
Both common femoral arteries (CFAs) are surgically exposed to allow bilateral access of diagnostic and therapeutic devices. The endoluminal stent graft is then deployed in accordance with the Instructions for Use.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Aneurysm diameter ≥ 4.0 cm; or aneurysm diameter ≤ 4.0 cm which has exhibited rapid expansion; or aneurysms with saccular configuration where potential for rupture is increased; or aneurysms which have exhibited dissection and there is potential for rupture or compromised flow to vital structures; or symptomatic leaking or ruptured aneurysms.
- Vessels proximal and distal to the lesion must be capable of accommodating the device.
- The access artery diameter and profile of the artery must be capable of the device delivery.
- Patients must be ASA III or higher.
- Informed consent must be obtainable.
- Patients must be willing and able to comply with the follow-up regime.
- Patients with neck grades as follow:
- Grade I: Length of Proximal Neck ≥ 1.5 cm and Distal Neck ≥ 1.0 cm
- Grade II: Length of Proximal Neck ≥ 1.5 cm, but Distal Neck < 1.0 cm without obvious iliac aneurysms, or aneurysm extends into or is associated with iliac aneurysms.
- Grade III: Length of Proximal Neck < 1.5 cm and Distal Neck ≥ 1.0 cm
- Grade IV: Length of Proximal Neck < 1.5 cm and Distal Neck < 1.0 cm or the involvement as in Grade II.
Exclusion Criteria:
- A proximal neck less than 0.5 cm in length.
- Arterial diameter larger than 40 mm at the proximal or distal landing zones.
- Iliac diameter less than 6 mm (following balloon angioplasty as needed).
- The inferior mesenteric artery is indispensable.
- Patients under the age of 18.
- Pregnant or lactating women.
- Patients with allergy to any of the device materials.
- Patients with uncorrectable coagulopathy or bleeding disorders.
- Patients for whom contrast medium or anticoagulation drugs are contraindicated.
- Patients with active systemic or localized groin infection.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549016
Contacts
| Contact: Russell Williams | 602-266-2200 ext 3604 | rwilliams@azheart.com |
Locations
| United States, Arizona | |
| Arizona Heart Institute | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Principal Investigator: Edward B Diethrich, M.D. | |
| Sub-Investigator: Julo Rodriguez-Lopez, M.D. | |
| Sub-Investigator: Venkatesh Ramaiah, M.D. | |
| Sub-Investigator: Rajagopalan Ravi, M.D. | |
Sponsors and Collaborators
Arizona Heart Institute
Investigators
| Principal Investigator: | Edward B Diethrich, M.D. | Arizona Heart Institute |
More Information
No publications provided
| Responsible Party: | Edward B. Diethrich, MD, Arizona Heart Institute |
| ClinicalTrials.gov Identifier: | NCT00549016 History of Changes |
| Other Study ID Numbers: | G020035 |
| Study First Received: | October 24, 2007 |
| Last Updated: | May 14, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Arizona Heart Institute:
|
Aneurysm Exclusion |
Additional relevant MeSH terms:
|
Aneurysm Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013