Coarctation Of the Aorta Stent Trial

NCT ID: NCT00552812

Last Updated: 2016-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2015-07-31

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.

Detailed Description

The goals of this study are to provide information that will support labeling of both the CP bare metal and covered stents to treat native and recurrent aortic coarctation in selected children, adolescents and adults. The investigation will have two phases: Phase One will examine the safety and efficacy of the bare metal stent, and will collect information about the covered stent when used as rescue therapy for aortic injuries occurring during bare metal stent procedures.

The aims of the Phase One study are to assess the use of the CP bare metal stent to:

1. provide a reduction equivalent to surgery in arm-leg systolic cuff blood pressure gradient 12 months after dilation and stent implantation, in comparison to the pre-dilation gradient;

2. accomplish gradient relief with a shorter number of days in hospital than surgery;

3. accomplish gradient relief with a rate of occurrence of serious procedure-related adverse events occurring within 30 days of dilation that is equivalent to surgery; and

4. accomplish gradient relief with a rate of occurrence of post-procedural paradoxical hypertension that is lower than surgery.

Conditions

Coarctation of the Aorta

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stent therapy of aortic coarctation

Stenting of aortic coarctation

Group Type: EXPERIMENTAL

Stent therapy of aortic coarctation

Intervention Type: DEVICE

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

Interventions

Stent therapy of aortic coarctation

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

Intervention Type: DEVICE

Other Intervention Names

Cheatham-Platinum Stent

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Richard E. Ringel

OTHER

Sponsor Role: lead

Responsible Party

Richard E. Ringel

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Richard E Ringel, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Kathy Jenkins, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Locations

Children's Hospital Boston

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38112942 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34039015 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25869198 (View on PubMed)

Other Identifiers

G060057

Identifier Type: -

Identifier Source: org_study_id