Coronary Angioplasty and StentingNCT02128412
IVUS Controlled Stenting
A study testing Oversized stent deployed at low pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent) and Stent deployed at high pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent) in people with Coronary Angioplasty and Stenting and Single de Novo Coronary Artery Stenoses, run by Sydney South West Area Health Service at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Angioplasty and Stenting, Single de Novo Coronary Artery Stenoses
- What is being tested?
- Oversized stent deployed at low pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent) and Stent deployed at high pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to antiplatelet therapy;
- Ostial lesion;
- Excessive vessel tortuosity;
- Lesion at a significant bifurcation (subbranch ≥ 2mm in diameter);
- Suspected intracoronary thrombus.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- 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)
- Keywords
- Patients scheduled to undergo coronary angioplasty and stenting because of symptoms related to a single de novo coronary artery stenoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oversized stent deployed at low pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)Device
Stent can include both bare metal stents and drug eluting stents. Depending on availabilities, different stent brands may be used.
Stent deployed at high pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)Device
Stent can include both bare metal stents and drug eluting stents. Depending on availabilities, different stent brands may be used.
| Study group | Role | What they receive |
|---|---|---|
| Stent oversize group | 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. Receives: Device: Oversized stent deployed at low pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent) |
| High pressure group | 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 Receives: Device: Stent deployed at high pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of stents which are optimally deployed as assessed against the MUSIC criteria
The criteria for optimal stent expansion are:
- 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
Measured: Immediately after stent is deployed until optimal deployment is achieved
Secondary outcomes (1)
Clinical endpoints including death, myocardial infarction, coronary artery bypass surgery, repeat percutaneous intervention, stent thrombosis, myonecrosis
Measured: 1-3 days following procedure and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2016
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Angioplasty and StentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sydney South West Area Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Esther Zhou, Sydney South West Area Health Service
- Investigators
- Craig Juergens, Cardiologist, Principal investigator, South West Sydney, Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128412
- Sponsor's protocol ID
- 2013/167
- Status last verified
- Oct 2016
- First submitted
- 28 Apr 2014
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expansion of Intracoronary Stents by Low Pressure Oversizing Versus High Pressure Inflation: A Randomised Intracoronary Ultrasound Controlled Study
- ClinicalTrials.gov ID
- NCT02128412
- Acronym / sponsor ID
- 2013/167
- Keywords
- Patients scheduled to undergo coronary angioplasty and stenting because of symptoms related to a single de novo coronary artery stenoses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sydney South West Area Health ServiceOther government
- Study start
- Feb 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (estimated)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent oversize group | Active comparator | Device: Oversized stent deployed at low pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)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. |
| High pressure group | Active comparator | Device: Stent deployed at high pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Contraindication to antiplatelet therapy;
- Ostial lesion;
- Excessive vessel tortuosity;
- Lesion at a significant bifurcation (subbranch ≥ 2mm in diameter);
- Suspected intracoronary thrombus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 oversize group |
| 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. | Device | High pressure group |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Juergens, Cardiologist principal investigator
South West Sydney, Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oversized stent deployed at low pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent) and Stent deployed at high pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent) in people with Coronary Angioplasty and Stenting and Single de Novo Coronary Artery Stenoses, run by Sydney South West Area Health Service at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.