NCT07202754

Brief Summary

The relative risks for different non-fatal intraprocedural complications during complex percutaneous coronary intervention (PCI) on subsequent mortality have not been described. This study aimed to assess the association between non-fatal intraprocedural complications and late mortality after complex coronary PCI.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Status
not yet 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

First Submitted

Initial submission to the registry

September 23, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 23, 2025

Last Update Submit

October 1, 2025

Conditions

Complex Coronary Artery Disease

Keywords

Complications, death, major adverse cardiac events, target vessel revascularization

Outcome Measures

Primary Outcomes (1)

  • Death

    All cause death

    up to 60 months

Study Arms (2)

Group 1

Non-fatal complications (+)

Group 2

Non-fatal complications (-)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Complex coronary lesions include chronic total occlusion, osteal epicardial lesions, long (diffuse) coronary disease, severe calcific lesions, true bifurcation disease, left main coronary lesion, lesions with severe thrombus, and in-stent restenosis.

You may qualify if:

  • Patients with complex coronary disease
  • Aged 18-85 years

You may not qualify if:

  • Patients diagnosed with cardiogenic shock
  • Coronary lesions with non-complex features
  • Percutaneous coronary intervention with a bare metal stent
  • Patient life expectancy \<1 year
  • Known relevant allergies
  • Absence of all medical records
  • Patients with early discontinuation of dual antiplatelet therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DeathCardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 2, 2025

Study Start

November 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share