Coronary Ostium StenosisPhase 4SBPSNCT01430377
Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)
A Phase 4 study testing SB predilatation and No SB predilatation in people with Coronary Ostium Stenosis and Myonecrosis, run by Medica Cor Heart Hospital at 1 site in Bulgaria.
Trial summary
The role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous coronary intervention (PCI) is still not established. The predilatation could potentially damage SB ostium by vessel dissection, making subsequent wiring problematic. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Coronary Ostium Stenosis, Myonecrosis
- What is being tested?
- SB predilatation and No SB predilatation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBulgaria
- Study dates
- Aug 2011to May 2012
- Phase
- Phase 4
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria
- Subject at least 18 years of age.
- Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
- Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.
- Exclusion Criteria
- ST-segment elevation myocardial infarction (STEMI)
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Subjects who refuse to give informed consent.
- Subjects with left ventricle ejection fraction <30%
- Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
- Contraindications for 12 months double antiplatelet therapy
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site, 1 recruiting
- Recruiting
Medica Cor Heart Hospital
Rousse, 7000
Dobrin I Vassilev, MD, PhD, 00359886846550, dobrinv@gmail.com
Hristo Popov, MD, 00359887686003, hrpopov@gmail.com
About this study
The role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous coronary intervention (PCI) is still not established. The predilatation could potentially damage SB ostium by vessel dissection, making subsequent wiring problematic. However, predilatation could eliminate SB ostial stenosis obviating need for further SB treatment after main vessel stent implantation. The aim of the study is to assess in random fashion the periprocedural myonecrosis, complication rates and time for SB rewiring in groups with and without SB predilatation.
- Conditions
- Coronary Ostium Stenosis, Myonecrosis
- Being tested
- SB predilatation, No SB predilatation
- Keywords
- periprocedural myonecrosis, procedure time, fluoroscopy time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB predilatationProcedure or surgery
Initial SB [predilatation.
No SB predilatationProcedure or surgery
Without SB predilatation
| Study group | Role | What they receive |
|---|---|---|
| SB predilatation | Experimental | Not described Receives: Procedure: SB predilatation; Procedure: No SB predilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for rewiring SB
Measured: 24h
Secondary outcomes (2)
Periprocedural myonecrosis
Measured: 24 h
MACE
death, MI, TVR
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Ostium StenosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medica Cor Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dobrin Vassilev MD, PhD, Medica Cor Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430377
- Sponsor's protocol ID
- SBPS
- Acronym
- SBPS
- Status last verified
- Sep 2011
- First submitted
- 3 Sep 2011
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)
- ClinicalTrials.gov ID
- NCT01430377
- Acronym / sponsor ID
- SBPS / SBPS
- Conditions
- Coronary Ostium Stenosis, Myonecrosis
- Keywords
- periprocedural myonecrosis, procedure time, fluoroscopy time
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medica Cor Heart HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 8 Sep 2011 (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 role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous coronary intervention (PCI) is still not established. The predilatation could potentially damage SB ostium by vessel dissection, making subsequent wiring problematic. However, predilatation could eliminate SB ostial stenosis obviating need for further SB treatment after main vessel stent implantation. The aim of the study is to assess in random fashion the periprocedural myonecrosis, complication rates and time for SB rewiring in groups with and without SB predilatation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SB predilatation | Experimental | Procedure: SB predilatation, Procedure: No SB predilatation |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SB predilatationInitial SB [predilatation. | Procedure or surgery | SB predilatation |
| No SB predilatationWithout SB predilatation | Procedure or surgery | SB predilatation |
Primary outcome
Time for rewiring SB
Time frame: 24h
2 secondary outcomes
Periprocedural myonecrosis
Time frame: 24 h
MACE
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2011.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SB predilatation and No SB predilatation in people with Coronary Ostium Stenosis and Myonecrosis, run by Medica Cor Heart Hospital at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Sep 2011. 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 Bulgaria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Dobrin I Vassilev, MD, PhD (00359886846550, dobrinv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for rewiring SB (time frame: 24h). 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 8 Sep 2011; AzTrials last refreshed its copy on 6 Nov 2026.