RecruitingNCT06223217

Development and Validation of the Modified Version of VascuQol Scale in Patients With Lower Extremity Peripheral Arterial Disease.


Sponsor

RenJi Hospital

Enrollment

480 participants

Start Date

Oct 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to assess the utility of the Modified version of VascuQol Scale as an effective biopsychosocial assessment tool for patients suffering from lower extremity peripheral arterial disease.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria6

  • Male or female aged 18-90
  • The patient is diagnosed with lower extremity peripheral arterial disease
  • The patient is willing to comply with specified follow-up evaluations at the specified times
  • The patient understands the nature of the procedure and provides written informed consent before enrolment in the study
  • Before enrolment, the guidewire has crossed the target lesion
  • No restrictions on Rutherford grading, TASC grading, GLASS grading

Exclusion Criteria4

  • Pregnant women or Female patients with potential childbearing
  • The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
  • Patients unwilling or refusing to sign informed consent
  • Patients with other diseases that may seriously affect the quality of life, such as tumors, severe liver disease, cardiac insufficiency, etc., or those with a life expectancy of less than 2 years

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Interventions

OTHERSurveys and Questionnaires

The intervention consists of completing the Chinese version of Vascu-QoL scale and the modified version of Vascu-QoL scale


Locations(1)

Renji Hospital

Shanghai, Shanghai Municipality, China

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NCT06223217


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