Trial Outcomes & Findings for Coarctation Of the Aorta Stent Trial (NCT NCT00552812)

Results Overview

Noninvasive systolic blood pressures are measured in the arms and legs at baseline and 12 month follow-up. The difference between these measurements are calculated. The difference between systolic arm and leg blood pressures decreased by 30 ± 22 mmHg (n=90)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

105 participants

Primary outcome timeframe

12 months

Results posted on

2016-03-11

Participant Flow

Recruitment opened February, 2008 and ended December, 2010

Patients were consented as outpatients, but final selection criteria were assessed in the catheterization laboratory

Participant milestones

Participant milestones
Measure	Coarctation Stenting Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
Overall Study STARTED	105
Overall Study COMPLETED	85
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coarctation Of the Aorta Stent Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Coarctation Stenting n=105 Participants Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
Age, Categorical <=18 years	67 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	16 years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants
Region of Enrollment United States	105 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Noninvasive systolic blood pressures are measured in the arms and legs at baseline and 12 month follow-up. The difference between these measurements are calculated. The difference between systolic arm and leg blood pressures decreased by 30 ± 22 mmHg (n=90)

Outcome measures

Outcome measures
Measure	Coarctation Stenting n=90 Participants Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months	30 mmHg Standard Deviation 22

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Study patients compared at baseline and within the 12 month follow up window: Baseline (n=105) compared to 12 month follow up (n=92)

Noninvasive Blood pressure is assessed at baseline and 12 months. The number of patients with a Systolic Blood Pressure \> 95th Percentile for Age and Gender is recorded at Baseline (n=105) and compared to 12 month follow up (n=92).

Outcome measures

Outcome measures
Measure	Coarctation Stenting n=105 Participants Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement Baseline	61 percentage of participants
Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement 12 month follow up	17 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Comparison between baseline(n=105) and 12 month follow up (n=92)

Measurement of difference between upper and lower extremities by noninvasive, automated measurement of four quadrant Systolic Blood Pressure. Comparison between baseline and 12 month follow up.

Outcome measures

Outcome measures
Measure	Coarctation Stenting n=105 Participants Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
Systolic Blood Pressure, Difference Between Upper and Lower Extremities Baseline	29 mmHg Standard Deviation 17
Systolic Blood Pressure, Difference Between Upper and Lower Extremities 12 months	-1 mmHg Standard Deviation 15

Adverse Events

Coarctation Stenting

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Coarctation Stenting n=105 participants at risk Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
Cardiac disorders Abnormal exercise echo test at one year	0.95% 1/105

Other adverse events

Other adverse events
Measure	Coarctation Stenting n=105 participants at risk Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
Vascular disorders Localized vascular tear	1.9% 2/105
Cardiac disorders Aortic Aneurysm	4.8% 5/105
Cardiac disorders Post-procedure hypertension	1.9% 2/105
Cardiac disorders Residual aortic obstruction	1.9% 2/105
Cardiac disorders Stent Malposition	0.95% 1/105
Cardiac disorders AV Fistula	0.95% 1/105
Vascular disorders Groin Hematoma	0.95% 1/105

Additional Information

Dr. Richard E. Ringel

Johns Hopkins School of Medicine

Phone: 410-614-6745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place