A Prospective Study of Discomfort Symptoms in Patients With Aortic Disease After Endovascular Intervention

NCT07114185 | Not Yet Recruiting

• 1 other identifier: IIT20250775B-R1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence and severity of post-procedural discomfort were evaluated in patients undergoing endovascular repair for aortic disease across six symptom-related dimensions: immobilization-related issues, puncture site discomfort, adhesive-induced skin reactions, post-stent implantation syndrome, impairment in self-care ability, and physical/psychological stress responses.

Conditions

Aortic Aneurysm and Dissection

Keywords

nursing; postoperative complication management

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative discomfort symptoms

  Based on six dimensions-immobilization-related, puncture site-related, adhesive-related skin reactions, aortic disease-related symptoms, self-care ability, and psychosomatic stress-patients were assessed at 6, 24, and 48 hours postoperatively using a structured questionnaire. The primary objective was to assess the incidence of postoperative complications and the severity of pain.

  6, 24, and 48 hours postoperatively

Study Arms (1)

1

Patients with aortic disease who received endovascular treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with aortic dissection undergoing endovascular treatment

You may qualify if:

• Diagnosed with thoracoabdominal aortic disease
• Patients who underwent endovascular treatment of the thoracoabdominal aorta via the femoral artery approach

You may not qualify if:

• Aortic disease caused by infection
• Aortic disease caused by trauma
• Aortic disease treated by open abdominal surgery
• Presence of systemic diseases uncontrollable by current medical standards (e.g., severe cardiac, pulmonary or hepatic dysfunction; advanced malignancy; cachexia; refractory severe coronary artery disease symptoms; coagulation disorders caused by genetic diseases, etc.)
• Patients who have undergone endovascular aortic treatment via femoral artery access prior to this procedure due to other diseases (not related to the current aortic disease)

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The first affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Central Study Contacts

xiaoya zhang

CONTACT

+8613516729415; 2470575102@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)