NCT02128412

IVUS Controlled Stenting

Expansion of Intracoronary Stents by Low Pressure Oversizing Versus High Pressure Inflation: A Randomised Intracoronary Ultrasound Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sydney South West Area Health Service · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Stent placement is now widely accepted to improve the results of angioplasty (an operation to widen the blood vessel) and decreasing the need for further surgery. Despite their worldwide acceptance, stent usage is still limited by renarrowing which occurs within the stent (restenosis) in some patients within the first six months. In addition there still exists a small risk of heart attacks soon after the stent is placed. The purpose of this study is to test the safety and tolerability of trying to place the stents using a different strategy of using low pressure oversized balloon inflations as opposed to the usual high pressure balloon inflations. This may reduce injury to the artery and reduce the chance of renarrowing of the stent. In order to ensure this is a safe and effective way of performing the procedure the investigators intend to use an Intravascular ultrasound (IVUS) catheter to look from inside the artery at the stents. IVUS has proven to be the best way of ensuring optimal stent placement. Primary hypothesis: Stents will be equally well expanded and apposed using a strategy of oversized stenting at normal inflation pressures ( \< 10 atmospheres ) as compared to high pressure inflation (≥14 atmospheres) as guided by intravascular ultrasound imaging. Secondary Hypothesis: There will be no difference in acute clinical endpoints (death, myocardial infarction, urgent revascularisation or stent thrombosis) using a strategy of oversized stenting at normal inflation pressure as compared to high pressure inflation. Tertiary Hypothesis: If the above is shown to be true the investigators would hope to expand the study in order to reveal a decrease in stent restenosis using a strategy of lower pressure balloon inflations. The investigators will assess the deployment characteristics of drug eluting versus bare metal stents

Conditions

• Coronary Angioplasty and Stenting
• Single de Novo Coronary Artery Stenoses

Interventions

Type	Name	Description
DEVICE	Oversized stent deployed at low pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)	Stent can include both bare metal stents and drug eluting stents. Depending on availabilities, different stent brands may be used.
DEVICE	Stent deployed at high pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)	Stent can include both bare metal stents and drug eluting stents. Depending on availabilities, different stent brands may be used.

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2014-05-01
• Last updated: 2016-10-17

Locations

1 site across 1 country: Australia