Marfan Syndrome Clinical Trial
— CARPE-CMDOfficial title:
Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices
NCT number | NCT02050113 |
Other study ID # | CARPE-01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2014 |
Est. completion date | March 2030 |
The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | March 2030 |
Est. primary completion date | March 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - A patient may be suitable for inclusion in the study if the patient has at least one of the following: 1. Aortic or aortoiliac aneurysm with diameter =5.5 cm 2. Aortic or aortoiliac aneurysm with a history of growth =1.0 cm per year, or clinical indication for aneurysm repair based on symptoms General Inclusion Criteria 1. Cannot be treated with a currently available non-modified approved device 2. Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device 3. At least 18 years of age 4. Not pregnant or breastfeeding 5. Willing and able to comply with five years of follow-up 6. Willing and able to provide informed consent prior to enrollment 7. No systemic or local infection that may increase the risk of endovascular graft infection 8. High risk for open surgical repair based on any of the factors below: a. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery b. Physiologic i. ASA Category III or higher ii. Age >70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD Exclusion Criteria: - Exclusion Criteria Medical Exclusion Criteria 1. Cultural objection to receipt of blood or blood products 2. Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol 3. Anaphylactic reaction to contrast that cannot be adequately pre-medicated 4. Uncorrectable coagulopathy 5. Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina) 6. Patient has active malignancy with life expectancy of less than 2 years 7. Patient has life expectancy less than two years Anatomical Exclusion Criteria 1. Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access 2. Proximal neck length =25 mm 3. Proximal neck, measured outer wall to outer wall on a sectional image (CT) 1. For use of Zenith Flex: diameter >32 mm or <18 mm 2. For use of Zenith TX2: diameter >38 mm or <24 mm (for proximal and distal neck diameter) 4. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm 5. Proximal neck diameter change over the length of the proximal seal zone >4 mm 6. Proximal seal site with a circumferential thrombus/atheroma 7. Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) <7.0 mm at any point along access length (prior to deployment) 8. Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) >21 mm at distal fixation site 9. Iliac artery distal fixation site <10 mm in length 10. Non-bifurcated segment of any artery to be stented < 15 mm in length 11. Artery to be stented with a maximum diameter <3 mm or >10 mm at the vessel ostium 12. Inability to maintain at least one patent hypogastric artery |
Country | Name | City | State |
---|---|---|---|
United States | UMass Memorial Health Care - University Campus | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Andres Schanzer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effectiveness of physician modified endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success | 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. | 12 months post procedure | |
Secondary | Incidence of Major Adverse Events | Major adverse events include death, myocardial infarction, stroke, respiratory failure, paralysis, bowel ischemia, and procedural blood loss of greater than 1 liter. | Within 30 days of the initial procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00763893 -
Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome
|
Phase 3 | |
Recruiting |
NCT05809323 -
Marfan Syndrome Moderate Exercise Trial II
|
N/A | |
Completed |
NCT04776668 -
Living With Marfan Syndrome and Your Aorta
|
||
Recruiting |
NCT01949233 -
The Oxford Marfan Trial
|
Phase 2 | |
Active, not recruiting |
NCT01145612 -
Atenolol Versus Losartan in the Prevention of Progressive Dilation of the Aorta in Marfan Syndrome
|
Phase 3 | |
Completed |
NCT00723801 -
Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome
|
Phase 3 | |
Completed |
NCT04641325 -
Marfan Syndrome Moderate Exercise Pilot
|
N/A | |
Recruiting |
NCT06257004 -
Genome-wide Epistasis for Cardiovascular Severity in Marfan Study
|
||
Completed |
NCT01322165 -
National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions
|
N/A | |
Recruiting |
NCT05700175 -
Transcriptomic Study of Adult Population With Marfan Syndrome
|
||
Completed |
NCT00782327 -
Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers
|
Phase 3 | |
Not yet recruiting |
NCT05838235 -
Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Marfan Syndrome
|
N/A | |
Recruiting |
NCT02148900 -
Development of a Blood Test for Marfan Syndrome
|
N/A | |
Active, not recruiting |
NCT05980104 -
Single-Session "Empowered Relief" Class for Marfan Syndrome and Related Conditions
|
N/A | |
Completed |
NCT00001641 -
Study of Heritable Connective Tissue Disorders
|
N/A | |
Completed |
NCT01715207 -
Comparison Study of the Effect of Aliskiren Versus Negative Controls on Aortic Stiffness in Patients With Marfan Syndrome Under Treatment With Atenolol
|
Phase 3 | |
Completed |
NCT05516043 -
Safety and Performance of POLYTHESE® Vascular Prosthesis
|
||
Recruiting |
NCT04776681 -
Living With Marfans and Your Aorta: Surgical Outcomes Study
|
||
Completed |
NCT03236571 -
Cardiorespiratory and Muscular Rehabilitation of Children and Young Adults With Marfan Syndrome.
|
N/A | |
Recruiting |
NCT00683124 -
Nebivolol Versus Losartan Versus Nebivolol+Losartan Against Aortic Root Dilation in Genotyped Marfan Patients
|
Phase 3 |