NCT06702748

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
452

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 25, 2024

Status Verified

October 1, 2024

Enrollment Period

9.8 years

First QC Date

November 21, 2024

Last Update Submit

November 21, 2024

Conditions

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

Keywords

Coronary Microvascular DysfunctionIndex of Microcirculatory ResistanceCoronary artery diseaserotational atherectomy

Outcome Measures

Primary Outcomes (1)

  • major adverse cardiac events

    the composite of cardiac death, myocardial reinfarction, target vessel revascularization, and readmission for unstable angina

    24 months after PCI

Secondary Outcomes (1)

  • target vessel failure

    24 months after PCI

Study Arms (2)

Coronary microvascular dysfunction

angio-IMR\>=25

Non-Coronary microvascular dysfunction

Angio-IMR\<25

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

88 Jiefang Road

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2024

First Posted

November 25, 2024

Study Start

January 1, 2015

Primary Completion

October 31, 2024

Study Completion

December 31, 2025

Last Updated

November 25, 2024

Record last verified: 2024-10

Locations

CN(1)