Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices (CARPE-CMD)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02050113|
Recruitment Status : Recruiting
First Posted : January 30, 2014
Last Update Posted : February 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|Complex Aortic Aneurysms Thoracoabdominal Aneurysms Pararenal Aneurysms Juxtarenal Aneurysms Marfan Syndrome Ehlers-Danlos Syndrome Loeys-Dietz Syndrome Aortic Arch Aneurysm||Device: Custom Made Fenestrated or Branched Stent Graft||Not Applicable|
Endovascular repair of complex aortic aneurysms is limited by the need to maintain blood flow to the critical organs that receive blood from the aorta, such as the kidneys, liver and intestines. While there are some commercially available devices that may treat some of these patients these devices may not be suitable or available for a given patient. In this study we will use custom made devices manufactured by Cook, Inc, Zenith t-Branch devices and off-the-shelf, FDA approved devices which are altered by creating fenestrations (holes) in the stent graft that allow additional stents to be inserted into the blood vessels that supply blood to these critical organs.
Determination of which type of endograft to use will be based on the patient's anatomy and the perceived urgency of the need for repair. This decision will be made by the study team and confirmed by a 3rd party reviewer who is not an investigator on the study team. After ensuring that a patient meets inclusion and exclusion criteria for participation in the CARPE-CMD study, the perceived urgency for repair will be evaluated given the 6-8 week required time for manufacture of a CMD device.
If the patient's aneurysm is not symptomatic and if, at the discretion of the treating surgeon, the patient is deemed safe to wait 8 weeks until repair, the patient will be considered non-urgent. Non-urgent patients will undergo repair with a CMD device.
If the patient's aneurysm is symptomatic and if, at the discretion of the treating surgeon, the patient is deemed unsafe to wait 8 weeks until repair, the patient will be considered urgent. Urgent patients will undergo repair with a t-branch device (if anatomy suitable) Urgent patients who do not have anatomy suitable to a t-branch device or patients who are not deemed safe to wait for the device to be obtained, will undergo repair with a physician modified device.
The device is inserted into the body through two small punctures or incisions in the groin. Small stents will be inserted through the stent graft fenestrations into the major blood vessels affected by the aneurysm so that blood flow is maintained to these organs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||March 2030|
|Estimated Study Completion Date :||March 2030|
Experimental: Endovascular repair
Endovascular repair of Complex Aortic Aneurysm using a physician modified stent graft. custom made device or arch branch device.
Device: Custom Made Fenestrated or Branched Stent Graft
The surgeon will place a custom made graft, t-Branch device or modify commercially available stent grafts to match the anatomy of the patient being treated. Small fenestrations (holes) will be made in the stent graft so that additional stents can be inserted through the fenestration and into the blood vessels that lead to the kidneys, intestines or liver. These stents allow blood to flow freely to these organs. If the aneurysm is in the aortic arch stents may be placed in the carotid and subclavian arteries. This surgery is done through small incisions in the groin and sometimes in the upper arm.
- The effectiveness of physician modified endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success [ Time Frame: 12 months post procedure ]Treatment success is a combination of technical success, and freedom at 12 months from the following: Type 1 and 3 Endoleaks, Stent migration of more than 10 mm, aortic aneurysm enlargement sac enlargement of more than 5 mm, aneurysm rupture and conversion to open repair.
- Incidence of Major Adverse Events [ Time Frame: Within 30 days of the initial procedure ]Major adverse events include death, myocardial infarction, stroke, respiratory failure, paralysis, bowel ischemia, and procedural blood loss of greater than 1 liter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050113
|Contact: Shauneen Valliere, MSN, NPfirstname.lastname@example.org|
|Contact: Andres Schanzer, MDemail@example.com|
|United States, Massachusetts|
|UMass Memorial Health Care - University Campus||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Shauneen Valliere, MSN, NP 508-856-1767 firstname.lastname@example.org|
|Contact: Andres Schanzer, MD 508-856-5599 email@example.com|
|Principal Investigator: Andres Schanzer, MD|
|Principal Investigator:||Andres Schanzer, MD||University of Massachusetts, Worcester|