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Prognostic Values of Coronary Microvascular Dysfunction Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention

Zhejiang University logo

Zhejiang University

Status

Active, not recruiting

Conditions

Coronary Arterial Disease (CAD)
Coronary Microvascular Dysfunction (CMD)

Study type

Observational

Funder types

Other

Identifiers

NCT06702748
20220940-3

Details and patient eligibility

About

The goal of this observational study is to learn about the long-term prognostic of coronary microvascular dysfuction in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention.

The main question it aims to answer is: Does the coronary microvascular dysfunction impact the outcomes in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention.

Participants will answer survey questions about their clinical outcomes for 2 years by telephone.

Full description

This study was a retrospective, multicenter observational investigation and approved by the local Human Research Ethics Committee and conducted in accordance with the principles outlined in the Helsinki Declaration.Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI were eligible for inclusion in the study. Exclusion criteria included target vessel was chronic total occlusion, poor angiographic image quality, failed RA and RA not used for severe coronary calcification.

Angiography-derived index of microcirculatory resistance was measured in the target vessel treated with RA pre-PCI and post-PCI and blinded and performed by an independent core laboratory.The follow-up entailed the utilization of a multipronged approach, encompassing clinic visits, medical record reviews and telephone contacts.

Enrollment

452 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI

Exclusion criteria

  • target vessel was chronic total occlusion, poor angiographic image quality, failed RA and RA not used for severe coronary calcification

Trial design

452 participants in 2 patient groups

Coronary microvascular dysfunction
Description:
angio-IMR\>=25
Non-Coronary microvascular dysfunction
Description:
Angio-IMR\<25

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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