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OpenTrials
Completed

NCT Number: NCT02788396

The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in STEMI Patients Undergoing PPCI

This study aims to assess the impact of NC balloon post-dilatation on coronary microcirculation in patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

About this study

Suboptimal stent deployment can lead to future stent failure. Thus, optimising stent deployment with non-compliant balloons (NC balloon) post dilatation (PD) at high pressures is an established strategy. In the context of ST segment elevation myocardial infarction (STEMI), PD has been correlated anecdotally with the no reflow phenomenon.

This study aims to determine the impact of stent post-dilation (PD) with NC balloons at high pressures on coronary microcirculation during PPCI by measuring the index of microcirculatory resistance (IMR) pre and post stent post-dilatation. Pre and post PD, an optical coherence tomography (OCT) study will be performed to assess stent deployment and identify parameters that predict the changes in IMR.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years of age
  • Acute symptoms onset with duration > 20 minutes
  • ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block
  • Infarct related artery with a diameter above 2.5 mm
  • Operator's intention to proceed to stent deployment (i.e. not refer for CABG or defer PCI)

Exclusion criteria

  • < 18 year of age
  • Symptoms duration > 12 hours
  • Unable to give informed consent
  • Previous bypass graft surgery
  • Previous myocardial infarction
  • Pregnancy
  • Known severe chronic kidney disease (creatinine clearance ≤30 mL/min), unless the patient is on dialysis
  • Unable to receive antiplatelets or anticoagulation (i.e. coagulation disorders, bleeding etc.)
  • Haemodynamic instability
  • Severe LMS disease
  • Culprit vessel diameter < 2.5 mm
  • Contraindications to adenosine
  • Any study lesion characteristic resulting in the expected inability to deliver OCT catheter to the lesion pre and post PD (e.g. moderate or severe vessel calcification or tortuosity)

Treatment and study plan

Primary outcomes

  1. Delta index of microcirculatory resistance (dIMR)

    Time frame: index procedure

    Delta index of microcirculatory resistance (dIMR) [dΙΜΡ = IMR post post-dilation (post IMR) - IMR pre post-dilation (pre IMR)]

Secondary outcomes

  1. Minimum stent area (MSA)

    Time frame: index procedure

    Pre and post dilatation minimum stent area

  2. Stent expansion

    Time frame: index procedure

    Pre and post dilatation stent expansion; defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100

  3. Stent mal-apposition

    Time frame: index procedure

    Stent mal-apposition pre and post dilatation; defined as a distance between the strut's luminal edge and luminal vessel wall of greater >200 μm for a length >600 μm (appreciable in >3 contiguous frames at a pull-back speed of 20 mm/sec

  4. Intra-stent plaque protrusion and thrombus

    Time frame: index procedure

    Pre and post dilatation intra-stent plaque protrusion and thrombus; defined as a mass attached to the luminal surface or floating within the lumen at least 200 μm beyond the luminal edge of a strut

  5. Stent edge dissections

    Time frame: index procedure

    Edge dissections pre and post dilatation, further defined as major and minor [major dissections defined as the ones with a dissection flap width greater or equal to 200 μm)

Sponsors and collaborators

Lead sponsor

Mid and South Essex NHS Foundation Trust

Other

Collaborators

  • Anglia Ruskin University

Registry information

Official study title

The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in ST Segment Elevation Myocardial Infarction (STEMI) Patients Undergoing Primary Percutaneous Coronary Intervention (PPCI)

Acronym: POSTDILSTEMI

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 2, 2016
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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