Coronary Angioplasty and Stenting Clinical Trial
Official title:
Expansion of Intracoronary Stents by Low Pressure Oversizing Versus High Pressure Inflation: A Randomised Intracoronary Ultrasound Controlled Study
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
| Status | Active, not recruiting |
| Enrollment | 40 |
| Est. completion date | November 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Department of Cardiology | Liverpool | New South Wales |
| Lead Sponsor | Collaborator |
|---|---|
| Sydney South West Area Health Service |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of stents which are optimally deployed as assessed against the MUSIC criteria | The criteria for optimal stent expansion are: 1. Complete apposition of the stent over its entire length against the vessel wall. 2a. In stent minimal luminal area (MLA) >= 90% of the average reference luminal area or >=100% of lumen area of the reference segment with the lowest lumen area. In stent lumen area of proximal stent entrance >= 90% of proximal lumen area. 2b. Where the instent luminal area is in excess of 9.0 mm2 , the following criteria apply: In stent MLA > 80% of the average reference lumen area or >=90% of lumen area of the reference segment with the lowest lumen area. In stent lumen area of proximal stent entrance >= 90% of proximal lumen area. 3. Symmetric stent expansion defined by lumen diameter (LD)min / LD max >= 0.7 A less rigorous criteria for stent expansion will also be assessed: In stent MLA > 80% of the average reference lumen area; & Complete apposition of the stent over its entire length against the vessel wall |
Immediately after stent is deployed until optimal deployment is achieved | Yes |
| Secondary | Clinical endpoints including death, myocardial infarction, coronary artery bypass surgery, repeat percutaneous intervention, stent thrombosis, myonecrosis | 1-3 days following procedure and at 6 months | No |