Clinical trial NCT02128412: IVUS Controlled Stenting
Official title: Expansion of Intracoronary Stents by Low Pressure Oversizing Versus High Pressure Inflation: A Randomised Intracoronary Ultrasound Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Angioplasty and Stenting
Single de Novo Coronary Artery Stenoses
Keywords: Patients scheduled to undergo coronary angioplasty and stenting because of symptoms related to a single de novo coronary artery stenoses
Lead sponsor: Sydney South West Area Health Service
Sponsor class: OTHER_GOV
First posted: 2014-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of stents which are optimally deployed as assessed against the MUSIC criteria
timeFrame: 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
timeFrame: 1-3 days following procedure and at 6 months
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: Department of Cardiology
state: New South Wales
Study officials:
affiliation: South West Sydney, Liverpool
name: Craig Juergens, Cardiologist
role: PRINCIPAL_INVESTIGATOR
References: