RecruitingNot ApplicableNCT06430892

RAPID-POP a Randomized Controlled Trial

Efficacy of the Pressure Optimization Protocol (POP )Versus Conventional Stent Deployment Strategy During Primary Percutaneous Coronary Intervention.


Sponsor

National Institute of Cardiovascular Diseases, Pakistan

Enrollment

400 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Efficacy of the Pressure Optimization Protocol (POP) versus Conventional Stent Deployment Strategy during Primary PCI: An Open Label Randomized Clinical Trial The investigators will compare conventional rapid stent inflation/deflation during primary PCI with higher pressure and prolonged duration of stent deployment Study Hypothesis: The POP in stent deployment is superior to the conventional stent deployment approach with a significantly higher achievement of the TIMI III flow, significantly lesser occurrence of slow flow/no-reflow, and significantly higher rate of ST-Segment resolution during primary PCI.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Patients aged 18 years and above.
  • Patients undergoing primary percutaneous coronary intervention (PCI) with stent implantation.
  • Presence of significant coronary artery stenosis (greater than 70% diameter reduction) confirmed by angiography.

Exclusion Criteria4

  • Patients with Killip class IV
  • Patients with significant comorbidities such as end-stage renal disease or advanced liver disease which may interfere with the procedure or follow-up.
  • Prior history of coronary artery bypass grafting (CABG).
  • Refusal to give consent for study participation or procedure

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Interventions

PROCEDUREPrimary Percutaneous Coronary Intervention (PPCI)

Patients presented with acute myocardial infarction undergoing primary percutaneous coronary intervention with stent deployment


Locations(1)

National institute of cardiovascular diseases

Karachi, Sindh, Pakistan

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NCT06430892


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