IVUS Controlled Stenting

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Sydney South West Area Health Service
Sponsor:
Information provided by (Responsible Party):
Esther Zhou, Sydney South West Area Health Service
ClinicalTrials.gov Identifier:
NCT02128412
First received: April 28, 2014
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Coronary Angioplasty and Stenting
Single de Novo Coronary Artery Stenoses
Device: Oversized stent deployed at low pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)
Device: Stent deployed at high pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Expansion of Intracoronary Stents by Low Pressure Oversizing Versus High Pressure Inflation: A Randomised Intracoronary Ultrasound Controlled Study

Resource links provided by NLM:


Further study details as provided by Sydney South West Area Health Service:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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:

    1. In stent MLA > 80% of the average reference lumen area; &
    2. Complete apposition of the stent over its entire length against the vessel wall


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stent oversize group

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.

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.
Active Comparator: High pressure group

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02128412

Contacts
Contact: Esther Zhou, Student +61425238879 estherzhou_93@hotmail.com
Contact: Craig Juergens, Cardiologist Craig.Juergens@sswahs.nsw.gov.au

Locations
Australia, New South Wales
Department of Cardiology Recruiting
Liverpool, New South Wales, Australia, 2170
Sub-Investigator: Esther Zhou, Student         
Principal Investigator: Craig Juergens, Cardiologist         
Sponsors and Collaborators
Sydney South West Area Health Service
Investigators
Principal Investigator: Craig Juergens, Cardiologist South West Sydney, Liverpool
  More Information

No publications provided

Responsible Party: Esther Zhou, Research Medical Student, Sydney South West Area Health Service
ClinicalTrials.gov Identifier: NCT02128412     History of Changes
Other Study ID Numbers: 2013/167
Study First Received: April 28, 2014
Last Updated: April 29, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Sydney South West Area Health Service:
Patients scheduled to undergo coronary angioplasty and stenting because of symptoms related to a single de novo coronary artery stenoses

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014