Trial Outcomes & Findings for Covered CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta (NCT NCT01278303)

Results Overview

Severity of Illness Scale (SIS) improvement increase of at least 1 grade from baseline to 12 month follow-up SIS is divided into 3 conditions \& 5 grades of severity: 1 = worst (reserved for AWI) , 5 = best) C1 Upper Extremity Systolic Blood Pressure (SBP) 2- \> 159 mmHg or any hpn on \>2 medications 3- 140-159 mmHg or elevated SBP on \>2 medications 4- 130-139 mmHg or normal SBP on \>2 medications 5- \<130 mmHg on 0-2 meds C2 Upper Extremity to Lower Extremity SBP difference 2- \>59 mmHg 3- 30-59 mmHg 4- 15-29 mmHg 5- \<15 mmHg C3 Aortic Wall Injury severity levels: 1. Uncontained rupture or large aneurysm 2. Contained rupture or stable large aneurysm 3. Small contained rupture or moderate aneurysm 4. Acute, but stable AWI or small aneurysm 5. No injury or minor aortic wall irregularity not in need of treatment. * Grades for conditions represent comparable degrees of illness (0 worst, 5 best) -Grade 0 denotes death related to coarctation or study therapy

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

82 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2023-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment of Aortic Wall Injury Repair of aortic wall injury with covered CP Stents Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.
Overall Study STARTED	82
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Covered CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment of Aortic Wall Injury n=82 Participants Repair of aortic wall injury with covered CP Stents Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.
Age, Continuous	18 years n=5 Participants
Age, Categorical <=18 years	41 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: Participants available for analysis at one year

Severity of Illness Scale (SIS) improvement increase of at least 1 grade from baseline to 12 month follow-up SIS is divided into 3 conditions \& 5 grades of severity: 1 = worst (reserved for AWI) , 5 = best) C1 Upper Extremity Systolic Blood Pressure (SBP) 2- \> 159 mmHg or any hpn on \>2 medications 3- 140-159 mmHg or elevated SBP on \>2 medications 4- 130-139 mmHg or normal SBP on \>2 medications 5- \<130 mmHg on 0-2 meds C2 Upper Extremity to Lower Extremity SBP difference 2- \>59 mmHg 3- 30-59 mmHg 4- 15-29 mmHg 5- \<15 mmHg C3 Aortic Wall Injury severity levels: 1. Uncontained rupture or large aneurysm 2. Contained rupture or stable large aneurysm 3. Small contained rupture or moderate aneurysm 4. Acute, but stable AWI or small aneurysm 5. No injury or minor aortic wall irregularity not in need of treatment. * Grades for conditions represent comparable degrees of illness (0 worst, 5 best) -Grade 0 denotes death related to coarctation or study therapy

Outcome measures

Outcome measures
Measure	Treatment of Aortic Wall Injury n=69 Participants Repair of aortic wall injury with covered CP Stents Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.
Study Participants With Grade 4 or 5 in Degree of Aortic Wall Injury (AWI) and/or Aortic Arch Obstruction Without Clinical Worsening	55 participants

SECONDARY outcome

Timeframe: 1 years

Secondary Efficacy Outcomes At One Year: (A) Number of participants with arm-leg systolic blood pressure (SBP) differences \<15 mmHg and (B) Number of participants with normal or only mildly elevated SBP, no more than mild arm-leg SBP, no clinically significant residual aortic wall injury AND no worsening in any of these three categories

Outcome measures

Outcome measures
Measure	Treatment of Aortic Wall Injury n=82 Participants Repair of aortic wall injury with covered CP Stents Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.
Secondary Efficacy Outcomes - 1 Year (A) arm-leg SBP difference <15 mmHg	54 participants
Secondary Efficacy Outcomes - 1 Year (B) Good clinical status at 1 yr w/o worsening	55 participants

SECONDARY outcome

Timeframe: 2 years

Secondary Safety Outcomes The proportion of patients experiencing any serious or somewhat serious adverse event related to the stent or implant procedure by 24 months follow up, such as: new aortic wall injury within the region of covered CP Stent implantation, stent malposition, stent fracture, aortic wall aneurysms (early or late), or restenosis requiring reintervention, arterial access site injury, bleeding, etc.

Outcome measures

Outcome measures
Measure	Treatment of Aortic Wall Injury n=82 Participants Repair of aortic wall injury with covered CP Stents Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.
Secondary Safety Outcomes - Adverse Events Serious Adverse Events	1.2 percentage of participants
Secondary Safety Outcomes - Adverse Events Somewhat Serious Adverse Events	11 percentage of participants

Adverse Events

Treatment of Aortic Wall Injury

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment of Aortic Wall Injury n=82 participants at risk Repair of aortic wall injury with covered CP Stents Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.
Cardiac disorders Aortic Wall Injury	1.2% 1/82 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Treatment of Aortic Wall Injury n=82 participants at risk Repair of aortic wall injury with covered CP Stents Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.
Cardiac disorders Arterial Wall Injury	2.4% 2/82 • Number of events 2 • 1 year
Cardiac disorders Aortic Wall Injury	4.9% 4/82 • Number of events 4 • 1 year
Infections and infestations Infection	1.2% 1/82 • Number of events 1 • 1 year
General disorders Pain or Discomfort	9.8% 8/82 • Number of events 8 • 1 year
Nervous system disorders Neurologic Injury	2.4% 2/82 • Number of events 2 • 1 year
Cardiac disorders Device Specific	9.8% 8/82 • Number of events 8 • 1 year
Cardiac disorders Non-Classified	2.4% 2/82 • Number of events 2 • 1 year
Cardiac disorders Arrhythmia	2.4% 2/82 • Number of events 2 • 1 year
Blood and lymphatic system disorders Bruising or Hemorrhage	11.0% 9/82 • Number of events 9 • 1 year

Additional Information

Dr. Richard E. Ringel

Johns Hopkins Hospital

Phone: 410-614-6745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place