Bifurcation Coronary DiseasePhase 3ABCNCT00914979
AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study)
A Phase 3 study testing AngioSculpt in people with Bifurcation Coronary Disease, run by HaEmek Medical Center, Israel at 4 sites in Israel.
Trial summary
Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bifurcation Coronary Disease
- What is being tested?
- AngioSculpt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 4 sitesIsrael
- Study dates
- Sep 2008to Sep 2011
- Phase
- Phase 3
- 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
Who may be able to join
- Patients with significant (≥ 50% diameter stenosis) native coronary artery disease involving a bifurcation (Medina class (x,x,1)).
Who cannot join
- Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
- Additional planned coronary interventions for a non-target lesion within 30 days of the study procedure.
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Khalid Suleiman
Afula, 18101
Oded Izenberg
Rehovot
Alexander Goldberg
Safed
Ricardo Krakover
Zrifin
About this study
Official title: AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study) Prospective, Multi-center, Non-randomized, Single-arm Registry
Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries.
Read the detailed description
The purpose of the AngioSculpt® Scoring Balloon Catheter For Bifurcation Coronary lesions (ABC registry) is to demonstrate the acute procedural success, device performance and long term outcome associated with use of the AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) for lesion preparation in the treatment of bifurcation lesions in native coronary arteries
- Conditions
- Bifurcation Coronary Disease
- Being tested
- AngioSculpt
- Keywords
- Angiosculpt, Bifurcation Lesion, Side branch, IVUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioSculptDevice
The AngioSculpt Scoring Balloon Catheter is a standard balloon dilatation catheter with a scoring balloon near the distal tip
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single Arm - Interventional Receives: Device: AngioSculpt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success ≤ 50% diameter stenosis of the main and the side branch at the conclusion of the procedure in the absence of in-hospital MACE
Measured: 9 Months
Secondary outcomes (4)
Rate of side branch stenting
Measured: 9 Months
Angiographic dissection rate and grade
Measured: 9 months
MACE rate at 30 days post-procedure
Measured: 9 months
Cumulative stent thrombosis and TLR rates at 9 months
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2011
- Study completionSep 2011
Why it stopped: Difficulties in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bifurcation Coronary DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khalid Suleiman, MD, Principal investigator, Heart Institute; Ha'Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914979
- Sponsor's protocol ID
- 0033 - 08 - EMC
- Acronym
- ABC
- Status last verified
- Jun 2015
- First submitted
- 4 Jun 2009
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study) Prospective, Multi-center, Non-randomized, Single-arm Registry
- ClinicalTrials.gov ID
- NCT00914979
- Acronym / sponsor ID
- ABC / 0033 - 08 - EMC
- Conditions
- Bifurcation Coronary Disease
- Keywords
- Angiosculpt, Bifurcation Lesion, Side branch, IVUS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting patients
- Enrolment
- 7 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 Jun 2009 (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.
Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries.
Detailed description
The purpose of the AngioSculpt® Scoring Balloon Catheter For Bifurcation Coronary lesions (ABC registry) is to demonstrate the acute procedural success, device performance and long term outcome associated with use of the AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) for lesion preparation in the treatment of bifurcation lesions in native coronary arteries
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: AngioSculptSingle Arm - Interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with significant (≥ 50% diameter stenosis) native coronary artery disease involving a bifurcation (Medina class (x,x,1)).
Key exclusion criteria (2 listed)
- Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
- Additional planned coronary interventions for a non-target lesion within 30 days of the study procedure.
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 |
|---|---|---|
| AngioSculptThe AngioSculpt Scoring Balloon Catheter is a standard balloon dilatation catheter with a scoring balloon near the distal tip | Device | 1 |
Primary outcome
Procedural success ≤ 50% diameter stenosis of the main and the side branch at the conclusion of the procedure in the absence of in-hospital MACE
Time frame: 9 Months
4 secondary outcomes
Rate of side branch stenting
Time frame: 9 Months
Angiographic dissection rate and grade
Time frame: 9 months
MACE rate at 30 days post-procedure
Time frame: 9 months
Cumulative stent thrombosis and TLR rates at 9 months
Time frame: 9 months
Results and safety
The study was stopped early (reason given: Difficulties in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
Related trials for Bifurcation Coronary Disease
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Not yet recruiting
Modified Jailed Balloon Technique vs Jailed Wire Technique in Coronary Bifurcation Intervention
Coronary Artery Disease
Enrolling by invitationObservational study
Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
RecruitingObservational study
Progress Bifurcation Global Registry
Coronary Artery Disease, Coronary Bifurcation Lesions
Recruiting
"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI
Coronary Artery Disease (CAD), Chronic Coronary Syndrome
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.
Khalid Suleiman, MD principal investigator
Heart Institute; Ha'Emek Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AngioSculpt in people with Bifurcation Coronary Disease, run by HaEmek Medical Center, Israel at 4 sites in Israel.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruiting patients). 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?
Procedural success ≤ 50% diameter stenosis of the main and the side branch at the conclusion of the procedure in the absence of in-hospital MACE (time frame: 9 Months). 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 23 Jun 2015.