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NCT Number: NCT07114185

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The first affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. The incidence of postoperative discomfort symptoms

    Time frame: 6, 24, and 48 hours postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

xiaoya zhang

CONTACT

[email protected]

+8613516729415

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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