Coronary AtherosclerosisBLASTNCT02316782
Bifurcation Lesion Analysis and STenting / BLAST
An observational study of Coronary Atherosclerosis, run by Volcano Corporation at 10 sites in 8 countries.
Trial summary
The purpose of this research study is to determine if Intravascular Ultrasound (IVUS) grayscale and VH (Virtual Histology)-IVUS pre-stenting can assess more accurately the location, amount, and type of a blockage than angiogram alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Atherosclerosis
- What is being tested?
- Blinded IVUS assessment and Nonblinded IVUS
- Type of treatment
- Medical device
- How many people
- 195 participants
- Where
- 10 sitesin 8 countries
- Study dates
- Oct 2008to Dec 2013
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Per Protocol Population All patients who met all inclusion/exclusion criteria, completed the study intervention procedure as described in the protocol, and completed the 1-month follow-up. Intent to Treat Any subject randomized into the trial and there was an attempt to use the IVUS but either side branch was not IVUS'd pre and post intervention.
Who may be able to join
- Patient must be greater than 18 years of age.
- Patient is scheduled for coronary stenting of a bifurcation lesion in a native artery using Drug Eluting Stents (DES).
- Patient must be willing and able to read and sign the informed consent document before planned coronary intervention.
- If the patient is female and of child bearing potential, a pregnancy test (serum HcG or urine dip stick) is negative within 7 days of the procedure.
- Side branch lumen diameter min of >2 mm by visual, angiographic estimate.
- Patient must agree to be available for follow-up at 30 days, 1 and 2 years after procedure.
- Other significant lesions in different vessels should be treated successfully (residual stenosis < 30%, normal TIMI flow, no EKG modification) before treating the index bifurcation lesion.
- -
Who cannot join
- The patient experiences significant hepatic disease, renal disease, lung disease and/or malignant disease with unfavorable prognosis.
- Any contraindications for IVUS interrogation as determined by the investigator including sever vessel tortuosity and severe calcification by angiogram.
- Side branch lumen diameter < 2 mm by visual, angiographic estimate.
- The patient suffered a cerebrovascular accident within the past 6 months and has residual effects from the event.
- The patient suffered significant (as determined by the Investigator) gastrointestinal bleeding within the past 3 months.
- The most recent white blood cell count less than 3,000 cell/mm3 or the number of platelet is less than 100,000 cell/mm3.
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- The patient has contraindication to antithrombotic regimen or anticoagulation therapy.
- Any other patients who are judged by principal Investigator to be inappropriate for participation in the trial.
- Existing hemorrhagic disease or coagulation problems creating inability to obtain homeostasis at entry site.
- The patient has history of or known reaction or sensitivity to contrast agent and is unable to be premedicated.
- Hemodynamic instability at the time of intervention.
- Severe chronic renal insufficiency (plasma/ serum creatinine > 2.5mg/dl) at the time of intervention, except for patients on dialysis.
- The lesion is 0.0.1. (Medina classification).
- The bifurcation lesion involves an anastamosis site from previous a coronary artery bypass surgery.
- Acute MI or recent MI with CPK > 3 times the normal value prior to intervention (during index hospitalization).
- Other significant lesion in the same vessel.
- Other lesion in a different vessel not successfully treated
- -
Trial locations and contacts
10 sites in 8 countries.
10 sites in 8 countries
France3 sites
Clinique Saint Augustin
Bordeaux
Hopital de la Cavale Blanche-CHU
Brest
Nouvelles Cliniques Nantaises
Nantes
United States1 site
Saint Luke's Hospital-Mid America Heart Institute
Kansas City, Missouri, 64111
Italy1 site
Azienda Sanitaria Ospedaliera Molinette San Giovanni Battista al Torino Departp Emodinamica Universitaria
Torino
About this study
The purpose of this research study is to determine if Intravascular Ultrasound (IVUS) grayscale and VH (Virtual Histology)-IVUS pre-stenting can assess more accurately the location, amount, and type of a blockage than angiogram alone. Additionally, this study is to determine if IVUS grayscale and VH-IVUS guidance will result in improved acute and long term procedural outcome vs. bifurcation stenting with only angiographic guidance in native coronary arteries.
Read the detailed description
Global multi-center, prospective, two-arm, randomized study. Patients will be randomized to either blinded or non-blinded IVUS assessment before the treatment of coronary bifurcation lesions. Treatment will be based either on grayscale and VH IVUS versus angiography alone.
After routine coronary angiogram, the physicians in the blinded arm of the study will only use the angiogram to guide the DES stenting procedure; the non-blinded arm will use the angiogram and IVUS grayscale and VH-IVUS to guide the procedure. In all patients, both pre- and post intervention, IVUS grayscale and VH-IVUS will be preformed on both branches of the bifurcation (blinded or non-blinded).
- Conditions
- Coronary Atherosclerosis
- Being tested
- Blinded IVUS assessment, Nonblinded IVUS
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded IVUS assessmentDevice
Only the angiogram is used for stent placement
Nonblinded IVUSDevice
Angiogram, Grayscale IVUS and VH IVUS used for stent placement pre and post intervention
| Study group | Role | What they receive |
|---|---|---|
| Non-blinded IVUS assessment | The non-blinded arm will use the angiogram and IVUS grayscale and VH-IVUS to guide the procedure. Receives: Device: Nonblinded IVUS | |
| Blinded IVUS assessment | After routine coronary angiogram, the physicians in the blinded arm of the study will only use the angiogram to guide the DES stenting procedure; Receives: Device: Blinded IVUS assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
IVUS with VH guidance leads to better post procedural outcomes when compared
The primary objective of this randomized study is to demonstrate that pre-intervention IVUS can provide more accurate information on lesion characteristics than information derived from pre-procedural angiogram alone. This will be determined by full lesion coverage, no acute evidence of plaque protrusion or dissection at the stent edge, no evidence of stent underexpansion, no evidence of stent malapposition, or no significant side branch disease left behind.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startOct 2008
- Primary completionDec 2010
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AtherosclerosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volcano Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thierry Lefevre, M.D., Principal investigator, Institute Hospitalier J Cartier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316782
- Sponsor's protocol ID
- RSC-001
- Acronym
- BLAST
- Status last verified
- Jun 2024
- First submitted
- 14 May 2014
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bifurcation Lesion Analysis and STenting / BLAST
- ClinicalTrials.gov ID
- NCT02316782
- Acronym / sponsor ID
- BLAST / RSC-001
- Conditions
- Coronary Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Volcano CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Dec 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.
The purpose of this research study is to determine if Intravascular Ultrasound (IVUS) grayscale and VH (Virtual Histology)-IVUS pre-stenting can assess more accurately the location, amount, and type of a blockage than angiogram alone. Additionally, this study is to determine if IVUS grayscale and VH-IVUS guidance will result in improved acute and long term procedural outcome vs. bifurcation stenting with only angiographic guidance in native coronary arteries.
Detailed description
Global multi-center, prospective, two-arm, randomized study. Patients will be randomized to either blinded or non-blinded IVUS assessment before the treatment of coronary bifurcation lesions. Treatment will be based either on grayscale and VH IVUS versus angiography alone.
After routine coronary angiogram, the physicians in the blinded arm of the study will only use the angiogram to guide the DES stenting procedure; the non-blinded arm will use the angiogram and IVUS grayscale and VH-IVUS to guide the procedure. In all patients, both pre- and post intervention, IVUS grayscale and VH-IVUS will be preformed on both branches of the bifurcation (blinded or non-blinded).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-blinded IVUS assessment | – | Device: Nonblinded IVUSThe non-blinded arm will use the angiogram and IVUS grayscale and VH-IVUS to guide the procedure. |
| Blinded IVUS assessment | – | Device: Blinded IVUS assessmentAfter routine coronary angiogram, the physicians in the blinded arm of the study will only use the angiogram to guide the DES stenting procedure; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Per Protocol Population All patients who met all inclusion/exclusion criteria, completed the study intervention procedure as described in the protocol, and completed the 1-month follow-up. Intent to Treat Any subject randomized into the trial and there was an attempt to use the IVUS but either side branch was not IVUS'd pre and post intervention.
Key inclusion criteria (8 listed)
- Patient must be greater than 18 years of age.
- Patient is scheduled for coronary stenting of a bifurcation lesion in a native artery using Drug Eluting Stents (DES).
- Patient must be willing and able to read and sign the informed consent document before planned coronary intervention.
- If the patient is female and of child bearing potential, a pregnancy test (serum HcG or urine dip stick) is negative within 7 days of the procedure.
- Side branch lumen diameter min of >2 mm by visual, angiographic estimate.
Key exclusion criteria (18 listed)
- The patient experiences significant hepatic disease, renal disease, lung disease and/or malignant disease with unfavorable prognosis.
- Any contraindications for IVUS interrogation as determined by the investigator including sever vessel tortuosity and severe calcification by angiogram.
- Side branch lumen diameter < 2 mm by visual, angiographic estimate.
- The patient suffered a cerebrovascular accident within the past 6 months and has residual effects from the event.
- The patient suffered significant (as determined by the Investigator) gastrointestinal bleeding within the past 3 months.
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 |
|---|---|---|
| Blinded IVUS assessmentOnly the angiogram is used for stent placement | Device | Blinded IVUS assessment |
| Nonblinded IVUSAngiogram, Grayscale IVUS and VH IVUS used for stent placement pre and post intervention | Device | Non-blinded IVUS assessment |
Primary outcome
IVUS with VH guidance leads to better post procedural outcomes when compared
Time frame: 2 years
The primary objective of this randomized study is to demonstrate that pre-intervention IVUS can provide more accurate information on lesion characteristics than information derived from pre-procedural angiogram alone. This will be determined by full lesion coverage, no acute evidence of plaque protrusion or dissection at the stent edge, no evidence of stent underexpansion, no evidence of stent malapposition, or no significant side branch disease left behind.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
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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.
Thierry Lefevre, M.D. principal investigator
Institute Hospitalier J Cartier
10 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Atherosclerosis, run by Volcano Corporation at 10 sites in 8 countries.
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 8 inclusion and 18 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: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, United States, Denmark, Italy, Latvia and 3 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IVUS with VH guidance leads to better post procedural outcomes when compared (time frame: 2 years). 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 Jun 2024.