Brief Summary
Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.
Brief Title
RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
Detailed Description
The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.
Completion Date
Completion Date Type
Estimated
Conditions
Aortic Aneurysm, Thoracic
Penetrating Ulcer
Eligibility Criteria
Inclusion Criteria:
* Subject must be ≥ 18 years of age
* Subject has specified disease in his/her descending thoracic aorta.
* Subject have anatomical compliance for the device specified for both access vessels and treatment area.
* Subject must be willing to comply with the follow-up evaluation schedule.
* Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment.
Exclusion Criteria:
* Subject has specified disease of the thoracic aorta which is not included in the trial, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, ruptured aneurysm.
* Subject anatomy with significant stenosis, calcification, thrombus or tortuosity.
* Subjects with specified compromised circulation.
* Subjects with specified prior procedures.
* Subjects with allergy to contrast media or device components.
* Subjects with disease, for example: suspected connective tissue disorder, specified coagulation disorders, specified coronary artery disease, severe congestive heart failure, stroke and/or Myocardial Infarction (MI) as specified, specified pulmonary disease, specified renal failure.
* Subjects that are pregnant or planning to become pregnant during the course of the study.
* Subject must be ≥ 18 years of age
* Subject has specified disease in his/her descending thoracic aorta.
* Subject have anatomical compliance for the device specified for both access vessels and treatment area.
* Subject must be willing to comply with the follow-up evaluation schedule.
* Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment.
Exclusion Criteria:
* Subject has specified disease of the thoracic aorta which is not included in the trial, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, ruptured aneurysm.
* Subject anatomy with significant stenosis, calcification, thrombus or tortuosity.
* Subjects with specified compromised circulation.
* Subjects with specified prior procedures.
* Subjects with allergy to contrast media or device components.
* Subjects with disease, for example: suspected connective tissue disorder, specified coagulation disorders, specified coronary artery disease, severe congestive heart failure, stroke and/or Myocardial Infarction (MI) as specified, specified pulmonary disease, specified renal failure.
* Subjects that are pregnant or planning to become pregnant during the course of the study.
Inclusion Criteria
Inclusion Criteria:
* Subject must be ≥ 18 years of age
* Subject has specified disease in his/her descending thoracic aorta.
* Subject have anatomical compliance for the device specified for both access vessels and treatment area.
* Subject must be willing to comply with the follow-up evaluation schedule.
* Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment.
* Subject must be ≥ 18 years of age
* Subject has specified disease in his/her descending thoracic aorta.
* Subject have anatomical compliance for the device specified for both access vessels and treatment area.
* Subject must be willing to comply with the follow-up evaluation schedule.
* Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02818972
Org Class
Industry
Org Full Name
Bolton Medical
Org Study Id
IP-0015-16
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
Primary Outcomes
Outcome Description
Primary safety endpoint is a composite of the following MAEs occurring through 30 days:
* Death
* Stroke (excluding transient ischemic attack)
* Paralysis (excludes paraparesis)
* Death
* Stroke (excluding transient ischemic attack)
* Paralysis (excludes paraparesis)
Outcome Measure
Rate of Major Adverse Events (MAEs)
Outcome Time Frame
30 days
Outcome Description
Primary effectiveness rate as measured by the technical success through 24 hours, defined as:
* Successful delivery of the device through the vasculature;
* Successful deployment of the device at the intended location; Absence of Type I or III endoleaks; Patent stent-graft without significant stenosis.
* Successful delivery of the device through the vasculature;
* Successful deployment of the device at the intended location; Absence of Type I or III endoleaks; Patent stent-graft without significant stenosis.
Outcome Measure
Technical success
Outcome Time Frame
24 hours
Outcome Description
Primary effectiveness as measured by the rate of stent-graft patency through 12 months.
Outcome Measure
Stent graft patency
Outcome Time Frame
12 months
Outcome Description
Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.
Outcome Measure
Aneurysm rupture
Outcome Time Frame
12 months
Outcome Description
Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months.
Outcome Measure
Absence of Type I and III endoleak through 12 months;
Outcome Time Frame
12 months
Outcome Description
Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months.
Outcome Measure
Absence of stent fractures in the attachment zone through 12 months
Outcome Time Frame
12 months
Outcome Description
Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months.
Outcome Measure
Absence of open or endovascular secondary interventions
Outcome Time Frame
12 months
Outcome Description
Primary effectiveness as measured by the absence of aneurysm expansion (\> 5 mm diameter increase) through 12 months, compared to the first post-procedural computed tomographic (CT) imaging study.
Outcome Measure
Absence of aneurysm expansion (> 5 mm diameter increase)
Outcome Time Frame
12 months
Outcome Description
Primary effectiveness as measured by the absence of stent-graft migration (\> 10 mm) through 12 months, compared to the first post-procedural CT.
Outcome Measure
Absence of stent-graft migration
Outcome Time Frame
12 months
Secondary Outcomes
Outcome Description
Loss of stent-graft patency will be assessed with CT scans, or MRIs for subjects unable to tolerate contrast media.
Outcome Time Frame
1 month and 6 months
Outcome Measure
Loss of stent-graft patency
Outcome Description
The rate of aneurysm rupture through 1 month and 6 months will be assessed by review of CT or MRI imaging, in addition to site reported adverse events.
Outcome Time Frame
1 month and 6 months
Outcome Measure
Rate of aneurysm rupture
Outcome Description
Persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft will be assessed by CT scans or MRIs for subjects unable to tolerate contrast media.
Outcome Time Frame
1 month, 6 months and 12 months
Outcome Measure
Rate of endoleaks of all types
Outcome Description
Stent fractures in the attachment zone will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media.
Outcome Time Frame
1 month and 6 months
Outcome Measure
Rate of stent fractures in the attachment zone
Outcome Description
Secondary effectiveness will be measured by the incidence of open or endovascular secondary interventions related to the device or treated pathology (ie, interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion).
Outcome Time Frame
1 month and 6 months
Outcome Measure
Incidence of open or endovascular secondary interventions
Outcome Description
The rate of aneurysm expansion (\> 5 mm diameter increase) assessed by comparison of follow-up imaging to the first post-procedural CT
Outcome Time Frame
1 month and 6 months
Outcome Measure
Rate of aneurysm expansion
Outcome Description
The rate of stent-graft migration (\> 10 mm) assessed by comparison of follow-up imaging to the first post-procedural CT.
Outcome Time Frame
1 month and 6 months
Outcome Measure
Rate of stent-graft migration
Outcome Description
Secondary effectiveness as measured by the individual outcomes of the composite safety endpoints (death, stroke, paralysis), as well as myocardial infarction (MI), renal failure, respiratory failure, bowel ischemia, and procedural blood loss \>1,000 cc.
Outcome Time Frame
6 months and 12 months
Outcome Measure
Individual outcomes of composite MAEs
Outcome Description
Secondary effectiveness as measured by the rate of vascular access complications reported during the Treatment visit (stent-graft implant). Outcome measures include successful delivery and deployment of the device, as well as withdrawal of the delivery system.
Outcome Time Frame
During the initial implant attempt
Outcome Measure
Rate of vascular access complications
Outcome Description
Duration of the initial implant procedure captured as the number of minutes from introduction of device to removal of delivery system.
Outcome Time Frame
Treatment Visit
Outcome Measure
Duration of implant procedure
Outcome Description
Number of transfusions (units) required from the time of implant through hospital discharge.
Outcome Time Frame
Treatment Visit through Discharge Visit
Outcome Measure
Number of blood transfusions
Outcome Description
Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure.
Outcome Time Frame
Treatment Visit through Discharge Visit
Outcome Measure
Duration of hospitalization
Outcome Description
Duration of time in hours that subject was admitted to the Intensive Care Unit (ICU) following the implant procedure.
Outcome Time Frame
Treatment Visit through Discharge Visit
Outcome Measure
Time in Intensive Care Unit (ICU)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Evan Lipsitz
Investigator Email
elipsitz@montefiore.org
Investigator Phone
Categories Mesh Debug
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- ARTERIOSCLEROSIS
Heart/Cardiovascular --- ARTERIAL OCCLUSIVE DISEASES
MeSH Terms
AORTIC ANEURYSM, THORACIC
PENETRATING ATHEROSCLEROTIC ULCER
AORTIC ANEURYSM
ANEURYSM
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
AORTIC DISEASES
ACUTE AORTIC SYNDROME
ARTERIOSCLEROSIS
ARTERIAL OCCLUSIVE DISEASES