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

NCT ID: NCT07114185

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-12-31

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.

Detailed Description

In this study, a customized postoperative discomfort symptom assessment questionnaire was developed based on patient-reported outcomes, aiming to systematically evaluate common discomfort symptoms experienced by patients with aortic disease after endovascular intervention. The questionnaire covers six core dimensions: immobilization-related discomfort, puncture site-related discomfort, adhesive-related skin reactions, post-stent implantation syndrome, decline in self-care ability, and psychosomatic stress responses. Each symptom within these dimensions was scored on a 0-4 scale according to severity: 0 indicates no symptoms; 1 indicates mild symptoms that are tolerable; 2 indicates moderate symptoms that affect daily life but are still tolerable; 3 indicates severe symptoms requiring medical intervention; and 4 indicates extremely severe symptoms that are intolerable and require emergency treatment.

Pain was evaluated using the Numeric Rating Scale (NRS). Skin reactions such as lesions, blisters, bruises, erythema, and rashes were quantified by measuring the longest and widest parts of the lesion using a flexible measuring tape. Self-care ability was assessed using the Activities of Daily Living (ADL) scale combined with patient self-evaluation

Conditions

Aortic Aneurysm and Dissection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Patients with aortic disease who received endovascular treatment

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with thoracoabdominal aortic disease

2. Patients who underwent endovascular treatment of the thoracoabdominal aorta via the femoral artery approach

Exclusion Criteria

1. Aortic disease caused by infection

2. Aortic disease caused by trauma

3. Aortic disease treated by open abdominal surgery

4. 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.)

5. 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

xiaoya zhang

Role: CONTACT

2470575102@qq.com

+8613516729415

Other Identifiers

IIT20250775B-R1

Identifier Type: -

Identifier Source: org_study_id