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Not yet recruitingNCT07114185Updated Aug 11, 2025

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

An observational study in Aortic Aneurysm and Dissection, sponsored by First Affiliated Hospital of Zhejiang University. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-08-11.

Primary conditionAortic Dissection(the registry's first term)UnverifiedIs this wrong?The registry often attaches Aortic Dissection to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by First Affiliated Hospital of Zhejiang University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Aortic Aneurysm and Dissection

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Keywords

  • nursing
  • postoperative complication management
03

In context

Aortic Dissection Unverified

205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.

This study's planned enrollment of 120 is below the median of 230 across 115 observational studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 263 studies on the registry; 144 are open to participants now.

Compared within Aortic Dissection, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with aortic dissection undergoing endovascular treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 ; cachexia; 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 1

    Patients with aortic disease who received endovascular treatment

06

What researchers measure

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.

    Time frame: 6, 24, and 48 hours postoperatively

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07114185
Responsible party
Sponsor
First posted
Aug 11, 2025
Start date
Jan 1, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 11, 2025

Study contacts

xiaoya zhang
Contact
2470575102@qq.com
+8613516729415

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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