Coarctation Of the Aorta Stent Trial

NCT00552812 | Completed Results DMC

• 1 other identifier: G060057
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Cheatham Platinum bare metal stents are safe and effective in the treatment of native and recurrent aortic coarctation in selected children, adolescents and adults.

Conditions

Coarctation of the Aorta

Keywords

Aortic Coarctation; Heart Defects, Congenital; Stents; Heart Catheterization

Outcome Measures

Primary Outcomes (1)

• Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 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)

  12 months

Secondary Outcomes (2)

• Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement

  Baseline and 12 months

• Systolic Blood Pressure, Difference Between Upper and Lower Extremities

  Baseline and 12 months

Study Arms (1)

Stent therapy of aortic coarctation

EXPERIMENTAL

Stenting of aortic coarctation

Device: Stent therapy of aortic coarctation

Interventions

Stent therapy of aortic coarctation DEVICE

Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.

Also known as: Cheatham-Platinum Stent

Stent therapy of aortic coarctation

Eligibility Criteria

• Age: 8 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Native or recurrent aortic coarctation
• Weight greater than or equal to 35 kg
• Noninvasive, arm-leg cuff systolic blood pressure difference or catheter measured systolic coarctation gradient greater than or equal to 20 mmHg

You may not qualify if:

• Age \> 60 years
• Connective tissue disorders, including Marfan syndrome and other genetic syndromes such as Turner syndrome and Noonan syndrome
• Inflammatory aortitis
• Bloodstream infection, including endocarditis
• Pregnancy
• Aortic aneurysm
• Prior stent placement
• Adults lacking capacity to consent
• Foster children and/or wards of the court

Sponsors & Collaborators

• Richard E. Ringel: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• Hu L, Sun Q, Tang L, Cai M, Qian W, Dou T, Wang H, Wu Y, Liu Y. Food Effect on the Pharmacokinetics of VC004, a Tropomyosin Receptor Kinase Inhibitor: A Randomized Crossover Trial in Healthy Chinese Subjects. Clin Drug Investig. 2024 Jan;44(1):79-85. doi: 10.1007/s40261-023-01334-y. Epub 2023 Dec 19.

  PMID: 38112942 DERIVED

• Holzer RJ, Gauvreau K, McEnaney K, Watanabe H, Ringel R. Long-Term Outcomes of the Coarctation of the Aorta Stent Trials. Circ Cardiovasc Interv. 2021 Jun;14(6):e010308. doi: 10.1161/CIRCINTERVENTIONS.120.010308. Epub 2021 May 27.

  PMID: 34039015 DERIVED

• Meadows J, Minahan M, McElhinney DB, McEnaney K, Ringel R; COAST Investigators*. Intermediate Outcomes in the Prospective, Multicenter Coarctation of the Aorta Stent Trial (COAST). Circulation. 2015 May 12;131(19):1656-64. doi: 10.1161/CIRCULATIONAHA.114.013937. Epub 2015 Apr 13.

  PMID: 25869198 DERIVED

MeSH Terms

Conditions

Aortic Coarctation; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Richard E. Ringel
• Organization: Johns Hopkins School of Medicine

rringel@jhmi.edu

410-614-6745

Study Officials

• Richard E Ringel, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Kathy Jenkins, MD

  Harvard University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 2, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2015
• Last Updated: March 11, 2016
• Results First Posted: September 25, 2014

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)