Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention (POST PCI)

S

Seung-Jung Park

Status

Completed

Conditions

Coronary Artery Disease With Myocardial Infarction

Treatments

Diagnostic Test: No Routine stress testing
Diagnostic Test: routine stress testing

Study type

Interventional

Funder types

Other

Identifiers

NCT03217877
AMCCV2017-05

Details and patient eligibility

About

The primary objective of the POST-PCI trial is to compare the clinical outcomes of a post-percutaneous coronary intervention(PCI) aggressive management strategy of routine noninvasive functional testing to a usual-care strategy of symptom-oriented functional testing in patients with high risk clinical, anatomical, and procedural characteristics who received PCI with contemporary drug-eluting stent and bioresorbable vascular scaffold.

Enrollment

1,700 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject was > 19 years of age.
  • Subjects who underwent successful percutaneous coronary intervention with contemporary drug eluting stent, contemporary Bioresorbable Scaffold or drug eluting balloon at In-stent restenosis (ISR) lesion.

Patients must have at least one of the following high-risk clinical, lesion, or procedure-related risk factors.

3-1. Clinical factors; diabetes, renal insufficiency/failure, enzyme positive acute coronary syndrome (ACS) (STEMI or NSTEMI).

3-2. Lesion- or procedure-related factors ; left main lesion, bifurcation lesion, ostial lesion, chronic total occlusion lesion, multivessel disease (≥ 2 vessels stented), restenotic lesion, diffuse long lesion (lesion length ≥30 mm or stent length ≥32 mm), or vein bypass graft stented

The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion criteria

  • Cardiogenic shock at the index admission
  • Subject treated with only bare metal stent or balloon angioplasty during the index procedure.
  • Pregnant and/or lactating women.
  • Concurrent medical condition with a life expectancy of less than 1 years
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

6 Subject was unable to provide written informed consent or participate in long-term follow-up.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,700 participants in 2 patient groups

No Routine stress testing after PCI
Active Comparator group
Treatment:
Diagnostic Test: No Routine stress testing
Routine stress testing at 9~15 months after PCI
Experimental group
Treatment:
Diagnostic Test: routine stress testing

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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