Ischemic Heart DiseaseCRABBISNCT05559424
Comparison of Results Achieved by Different Ballooning Techniques in Bifurcation Stenting
A study testing OCT in people with Ischemic Heart Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Single-stent strategy with provisional approach represents the gold standard for percutaneous coronary intervention of bifurcation lesions, and, according to European Bifurcation Club, performing provisional approach presents two steps considered as mandatory: "crossover stenting" in main vessel (MV) and subsequent… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- OCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2022to Jul 2023
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Clinical inclusion criteria:
- Subject has coronary artery disease involving a bifurcation with evidence of myocardial ischemia, including patient with chronic coronary syndromes, unstable angina, or non-ST elevation-acute coronary syndromes (NSTE-ACS) hemodynamically stable.
- Subject is suitable to be treated by PCI according to operator's judgement or heart team decision.
- PCI planning includes provisional stenting and image guidance by OCT use.
- Patient is aged ≥ 18 years.
- Patient can provide written informed consent
Angiographic inclusion criteria:
- De novo coronary lesion involving the left main bifurcation, or a bifurcation lesion not located in the left main with large branches (distal MV reference diameter ≥ 3.5 mm and SB reference diameter ≥ 2.75 mm on visual estimation)
Clinical exclusion criteria:
- Acute coronary syndromes with ST-elevation (STE-ACS)
- Cardiogenic shock
- LVEF ≤ 30%
- Pregnancy
- Known severe thrombocytopaenia (platelet count < 50,000/mm3)
- eGFR ≤ 30 mL/min/m2 (Cockcroft-Gault)
- Contraindications to antiplatelet drugs/anticoagulant drugs
- Significant allergic reactions for contrast agent
- Women with pregnancy potential.
Angiographic exclusion criteria:
- Target chronic total occlusion
- Planned 2 stent-strategy
- Target bifurcation lesion has a previously implanted stent
- Target graft lesions
- Medina 0.0.1 target lesions
Trial locations and contacts
1 site in 1 country.
Italy1 site
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
Rome, 00168
About this study
Official title: Head-to-head Comparison of Stent Geometry Obtained by Different Ballooning Techniques in Large Bifurcations Treated by Provisional Stenting
Single-stent strategy with provisional approach represents the gold standard for percutaneous coronary intervention of bifurcation lesions, and, according to European Bifurcation Club, performing provisional approach presents two steps considered as mandatory: "crossover stenting" in main vessel (MV) and subsequent post-dilation or "POT" (proximal optimization technique). While consensus exists regarding these first two steps, the exact optimal following sequence in case of side branch (SB) jeopardize after main vessel stenting is still a matter of debate.
Actually, the two most used techniques in this setting are represented by the simultaneous inflation of two balloons located respectively in the MV and SB followed by a second POT (POT/kissing balloon/POT technique) and the isolated inflation of a balloon placed in the SB followed by a second POT (POT/SIDE/POT technique).
The objective of this study is to compare the configuration achieved with POT/KISS/POT (PKP) and POT/SIDE/POT (PSP), using the "cutting edge" high-resolution intracoronary imaging modality (Optical Coherence Tomography, OCT).
Read the detailed description
A preclinical phase of the study (CRABBS-VHL) was performed in isolated porcine hearts comparing the two common side-branch (SB) optimization techniques after stent implantation in the main vessel (MV): proximal optimization technique (POT) + kissing balloon inflation + final POT (PKP arm) and POT + isolated balloon inflation + final POT (PSP arm).
A total of 30 PCIs were successfully performed. Baseline characteristics of treated bifurcations were similar between the two study arms. Minimum stent expansion at the distal main vessel (MV) segment was significantly lower with PSP as compared with PKP as assessed by both OCT and Micro-CT . Other significant findings included: higher stent eccentricity index at proximal MV with PSP, higher SB scaffolding length and lower malapposition (at bifurcation core and distal MV) with PKP.
These data need to be confirmed by further randomized studies in humans.
- Conditions
- Ischemic Heart Disease
- Being tested
- OCT
- Keywords
- Provisional, OCT, kissing balloon, bifurcations
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDiagnostic test
OCT will be used to assess results after intervention
| Study group | Role | What they receive |
|---|---|---|
| POT/KISSING/POT (PKP) | Active comparator | * SB rewiring is performed with the objective to cross "distal" stent struts (distal rewiring) through pullback technique.
* KBI is performed using short non-compliant balloons (balloon of MV sized in a 1:1 ratio with distal MV reference diameter and SB balloon sized in a 1:1 ratio with SB reference diameter), with sequential followed by simultaneous inflation.
* Final POT is performed at the same way as initial POT Receives: Diagnostic Test: OCT |
| POT/SIDE/POT (PSP) | Active comparator | * SB rewiring is performed with the objective to cross "distal" stent struts (distal rewiring) through pullback technique.
* SB dilatation is performed with a balloon sized 1:1 according to SB reference diameter.
* Final POT is performed at the same way as initial POT. Receives: Diagnostic Test: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent expansion
Minimum stent expansion
Measured: Intra-procedural
Secondary outcomes (10)
Side branch ostial scaffolding length
difference between maximal stent diameter at bifurcation core and distal reference diameter
Measured: Intra-procedural
Stent eccentricity index
SEI = minimum stent diameter/maximum stent diameter
Measured: Intra-procedural
Stent complications
Stent under-expansion
Measured: Intra-procedural
Additional treatment after OCT
need of additional treatment after assessment of results by OCT
Measured: Intra-procedural
Stent malapposition
Stent malapposition
Measured: Intra-procedural
Stent proximal edge dissection
Stent proximal edge dissection
Measured: Intra-procedural
Tissue prolapse
Tissue prolapse
Measured: Intra-procedural
Intracoronary thrombus
Intracoronary thrombus
Measured: Intra-procedural
Side branch ostium dissection
Side branch ostium dissection
Measured: Intra-procedural
Stent complicatons
In-stent dissection
Measured: Intra-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Before enrollment start, the plausibility of the study hypothesis will be verified in an experimental pilot randomized investigation conducted n an ex-vivo beating heart animal model
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Burzotta, Catholic University of the Sacred Heart
- Investigators
- Francesco Burzotta, MD, PhD, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559424
- Sponsor's protocol ID
- ID 5053
- Acronym
- CRABBIS
- Status last verified
- Oct 2022
- First submitted
- 26 Sep 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-to-head Comparison of Stent Geometry Obtained by Different Ballooning Techniques in Large Bifurcations Treated by Provisional Stenting
- ClinicalTrials.gov ID
- NCT05559424
- Acronym / sponsor ID
- CRABBIS / ID 5053
- Conditions
- Ischemic Heart Disease
- Keywords
- Provisional, OCT, kissing balloon, bifurcations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 29 Sep 2022 (actual)
- 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.
Single-stent strategy with provisional approach represents the gold standard for percutaneous coronary intervention of bifurcation lesions, and, according to European Bifurcation Club, performing provisional approach presents two steps considered as mandatory: "crossover stenting" in main vessel (MV) and subsequent post-dilation or "POT" (proximal optimization technique). While consensus exists regarding these first two steps, the exact optimal following sequence in case of side branch (SB) jeopardize after main vessel stenting is still a matter of debate.
Actually, the two most used techniques in this setting are represented by the simultaneous inflation of two balloons located respectively in the MV and SB followed by a second POT (POT/kissing balloon/POT technique) and the isolated inflation of a balloon placed in the SB followed by a second POT (POT/SIDE/POT technique).
The objective of this study is to compare the configuration achieved with POT/KISS/POT (PKP) and POT/SIDE/POT (PSP), using the "cutting edge" high-resolution intracoronary imaging modality (Optical Coherence Tomography, OCT).
Detailed description
A preclinical phase of the study (CRABBS-VHL) was performed in isolated porcine hearts comparing the two common side-branch (SB) optimization techniques after stent implantation in the main vessel (MV): proximal optimization technique (POT) + kissing balloon inflation + final POT (PKP arm) and POT + isolated balloon inflation + final POT (PSP arm).
A total of 30 PCIs were successfully performed. Baseline characteristics of treated bifurcations were similar between the two study arms. Minimum stent expansion at the distal main vessel (MV) segment was significantly lower with PSP as compared with PKP as assessed by both OCT and Micro-CT . Other significant findings included: higher stent eccentricity index at proximal MV with PSP, higher SB scaffolding length and lower malapposition (at bifurcation core and distal MV) with PKP.
These data need to be confirmed by further randomized studies in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before enrollment start, the plausibility of the study hypothesis will be verified in an experimental pilot randomized investigation conducted n an ex-vivo beating heart animal model
| Arm | Type | Receives |
|---|---|---|
| POT/KISSING/POT (PKP) | Active comparator | Diagnostic Test: OCT* SB rewiring is performed with the objective to cross "distal" stent struts (distal rewiring) through pullback technique. * KBI is performed using short non-compliant balloons (balloon of MV sized in a 1:1 ratio with distal MV reference diameter and SB balloon sized in a 1:1 ratio with SB reference diameter), with sequential followed by simultaneous inflation. * Final POT is performed at the same way as initial POT |
| POT/SIDE/POT (PSP) | Active comparator | Diagnostic Test: OCT* SB rewiring is performed with the objective to cross "distal" stent struts (distal rewiring) through pullback technique. * SB dilatation is performed with a balloon sized 1:1 according to SB reference diameter. * Final POT is performed at the same way as initial POT. |
Who may qualify
- Ages
- 18 to 100 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 |
|---|---|---|
| OCTOCT will be used to assess results after intervention | Diagnostic test | POT/KISSING/POT (PKP), POT/SIDE/POT (PSP) |
Primary outcome
Stent expansion
Time frame: Intra-procedural
Minimum stent expansion
10 secondary outcomes
Side branch ostial scaffolding length
Time frame: Intra-procedural
Stent eccentricity index
Time frame: Intra-procedural
Stent complications
Time frame: Intra-procedural
Additional treatment after OCT
Time frame: Intra-procedural
Stent malapposition
Time frame: Intra-procedural
Stent proximal edge dissection
Time frame: Intra-procedural
Tissue prolapse
Time frame: Intra-procedural
Intracoronary thrombus
Time frame: Intra-procedural
Side branch ostium dissection
Time frame: Intra-procedural
Stent complicatons
Time frame: Intra-procedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Francesco Burzotta, MD, PhD principal investigator
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT in people with Ischemic Heart Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 18 Oct 2022. 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 Italy. 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?
Contact Francesco Burzotta, MD, PhD (+390650156622, francesco.burzotta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent expansion (time frame: Intra-procedural). 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 18 Oct 2022.