Safety and Efficacy of Bioresorbable Iron-Based Covered Stent System for the Treatment of Coarctation of the Aorta: A Single-Center Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 60
Healthy Volunteers: f
View:

• Patient must between 1 and 60 years old

• Patients being clinically diagnosed with CoA or patients with post-operative anastomotic stenosis after CoA surgery,meanwhile meeting one of the following conditions:

• A:Pressure gradient of Carctation in a calm state. B:The degree of aortic stenosis is not less than 50% (degree of Carctation Of the Arota = (diameter of adjacent normal segment of blood vessel - residual vessel lumen diameter of stenotic segment)

⁃ diameter of adjacent normal segment of blood vessel×100% ) C:Peak velocity of echocardiographic Doppler in the CoA≥2.5m/s

• The patients and their families have high compliance, sign the informed consent and willing to undergo 1-year follow-ups and related examinations.

• The patient's expected lifespan is more than one year after successful treatment with the stent.

• Reference vessel (diameter of the adjacent normal segment vessel ) diameter:4-16mm

Locations
Other Locations
China
Fuwai Central China Cardiovascular Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Shubo Song, MD
songshubo9195@163.com
13523535453
Time Frame
Start Date: 2024-08-16
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 10
Treatments
Experimental: TBSI-CoA
Transcatheter bioresorbable iron-based covered stent implantation for the patients with coarctation of the aorta
Related Therapeutic Areas
Sponsors
Leads: Shubo Song
Collaborators: Central China Fuwai Hospital of Zhengzhou University

This content was sourced from clinicaltrials.gov