Overview

This trial is active, not recruiting.

Conditions coronary angioplasty and stenting, single de novo coronary artery stenoses
Treatments oversized stent deployed at low pressure (multi-link bare metal stent or xience prime evenolimus eluting stent), stent deployed at high pressure (multi-link bare metal stent or xience prime evenolimus eluting stent)
Sponsor Sydney South West Area Health Service
Start date February 2014
End date October 2016
Trial size 40 participants
Trial identifier NCT02128412, 2013/167

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Oversized stent deployed at low pressure: A stent premounted on a balloon with a nominal diameter halfway between the lumen diameter and the true vessel diameter (approximated by external elastic lamina) as assessed by IVUS. This will be based on the smallest of the vessel reference diameters proximal and distal to the lesion. In addition the vessel diameter must be greater than this diameter throughout the length of the lesion. This stent will be implanted at an inflation pressure of 10 atmospheres or less for at least 15 seconds and a second IVUS will be performed to assess the end point.
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.
(Active Comparator)
Stent deployed at high pressure: A stent premounted on a balloon with a nominal diameter approximately equal to the vessel segment lumen reference diameter as previously assessed by IVUS will be used. This stent will be implanted at an inflation pressure of 14 atmospheres or more for at least 15 seconds and a second IVUS will be performed to assess the end point
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.

Primary Outcomes

Measure
Number of stents which are optimally deployed as assessed against the MUSIC criteria
time frame: Immediately after stent is deployed until optimal deployment is achieved

Secondary Outcomes

Measure
Clinical endpoints including death, myocardial infarction, coronary artery bypass surgery, repeat percutaneous intervention, stent thrombosis, myonecrosis
time frame: 1-3 days following procedure and at 6 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - Patients who are scheduled for a coronary angioplasty and stenting - Single de novo artery stenosis are eligible for this study - Target lesion needs to be less than 30mm long and located in a vessel more than 2.5 mm in diameter Exclusion Criteria: - Contraindication to antiplatelet therapy; - Ostial lesion; - Excessive vessel tortuosity; - Lesion at a significant bifurcation (subbranch ≥ 2mm in diameter); - Suspected intracoronary thrombus.

Additional Information

Official title Expansion of Intracoronary Stents by Low Pressure Oversizing Versus High Pressure Inflation: A Randomised Intracoronary Ultrasound Controlled Study
Principal investigator Craig Juergens, Cardiologist
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Sydney South West Area Health Service.