Coronary Artery DiseaseNCT06484647
Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation
An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by San Luigi Gonzaga Hospital at 1 site in Italy.
Trial summary
Nowadays, no studies compare the T-stenting And Minimal Protrusion (TAP) and External Minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease, Chronic Coronary Syndrome
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 382 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 1 Oct 2024
- How long will I take part?
- 5 Years
- 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
- Adult, Older adult
Study population: ACS or CCS patients with complex coronary bifurcation lesions with the indication of PCI.
Who may be able to join
- Patients >18 years of age
- Patients with an indication for PCI, including chronic coronary syndrome and acute coronary syndromes (STEMI, NSTEMI, unstable angina)
- Patients with at least one true coronary bifurcation according to the Medina classification 1.1.1, 0.1.1, 1.0.1, 0.0.1
Who cannot join
- Patients who do not want or cannot sign the informed consent for the procedure.
- Patients with severe peripheral vascular disease that limits vascular access to the point of making the procedure unsafe.
- Patients with a life expectancy of <1 year.
- Patients with planned major surgery require prolonged discontinuation of antiplatelet therapy.
- Pregnant women.
- Patients who cannot take antiplatelet therapy for any reason.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Rivoli Hospital
Rivoli, Turin, 10098
Giulio Piedimonte, MD, +393201764900, giulio.piedimonte@gmail.com
Enrico enrico.cerrato@gmail.com, MD, +393479317104, enrico.cerrato@gmail.com
About this study
Official title: Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation: Insights From TREX Registry
Nowadays, no studies compare the T-stenting And Minimal Protrusion (TAP) and External Minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.
Read the detailed description
- According to DEFINITION criteria, PCI of the complex coronary bifurcation with up-front two stent techniques is associated with lower target vessel revascularization (TVR) compared to Provisional Stenting
- The Double-Kissing Crush stenting (DK-Crush) has been tested with the Culotte and the Classic Crush techniques in the unprotected left main disease (ULMD) and in no-ULMD setting, respectively, showing better clinical outcomes.
- However, due to its technical complexity and simultaneous improvement of the Classic Crush technique evolving in the External Minicrush, it has meant that the latter has become the most used technique in the clinical practice in treating complex coronary bifurcation
- The DK-Crush technique has never been tested with the External Minicrush, leaving the operators to choose one or the other according to their experience and preferences.
- The T-stenting And Minimal Protrusion (TAP) is a two-stent technique described to treat coronary bifurcation after provisional treating. Compared to crush techniques, it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting.
- Nowadays, no studies compare theTAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.
- The issue's importance is highlighted by higher rates of stent thrombosis (ST) and in-stent restenosis (ISR) of the two stent techniques compared to Provisional Stenting in treating coronary bifurcation8.
- Consequently, investigating the efficacy and safety differences between the techniques could improve the treatment of complex coronary bifurcation to reduce post-PCI TLR.
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease, Chronic Coronary Syndrome, Acute Coronary Syndrome
- Being tested
- Percutaneous Coronary Intervention
- Keywords
- Percutaneous Coronary Intervention (PCI), Coronary Artery Disease (CAD), Coronary Bifurcation Lesion (CBL)
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Percutaneous coronary intervention is a procedure that require coronary stenosis dilatation with dilatation catheter balloon and generally stent implantation.
The study involve coronary stenosis at bifurcation level that require complex coronary techniques such as External Minicrush or TAP technique.
| Study group | Role | What they receive |
|---|---|---|
| T-stenting And Minimal Protrusion | Percutaneous coronary intervention is performing according to current coronary Revascularization guidelines (ACC/ESC).
The vascular access is chosing according patients characteristics and operator preferences and require radial or femoral insertion of the sheath.
Antiplatelets strategy is a discretion of the operator and is depending on clinical presentation of the patients and respect the current guidelines (i.e Clopidogrel 600 mg load dose following 75 mg/daily, Ticagrelor 180 mg load dose following 180 mg/daily, Prasugrel 60 mg load dose following 10 mg/daily).
The procedural steps of the technique are described below:
* MV stenting
* Distal rewiring towards SB
* Kissing Balloon for opening distal struts towards SB
* SB stent implantation
* Final Kissing Balloon Receives: Procedure: Percutaneous Coronary Intervention | |
| External Minicrush | Percutaneous coronary intervention is performing according to current coronary Revascularization guidelines (ACC/ESC).
The vascular access is chosing according patients characteristics and operator preferences and require radial or femoral insertion of the sheath.
Antiplatelets strategy is a discretion of the operator and is depending on clinical presentation of the patients and respect the current guidelines (i.e Clopidogrel 600 mg load dose following 75 mg/daily, Ticagrelor 180 mg load dose following 180 mg/daily, Prasugrel 60 mg load dose following 10 mg/daily).
The procedural steps of the technique are described below:
* SB stent deployment with protrusion into MB
* Crush the SB stent with a balloon inflating into MB (>0.5 mm of the SB stent)
* MB stent deployment
* Rewiring
* POT
* KBI
* Final POT technique Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
a composite of cardiac death and target vessel-related myocardial infarction (TV-MI), including Q wave, non-Q wave myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)
Measured: 5-years
Secondary outcomes (3)
Stent thrombosis (ST)
Thrombosis of the stent after PCI
Measured: 5-years
Intrastent-restenosis (ISR)
Intrastent restenosis with >50% of the stent diameter
Measured: 5-years
Target Vessel MI (TVMI)
Target vessel myocardial infarction at follow-up
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 382 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- San Luigi Gonzaga Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Cerrato, San Luigi Gonzaga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484647
- Sponsor's protocol ID
- 001-2024
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piedimonte G, Cerrato E, Azzalini L, Quiros A, Di Fonzo R, Maffi V, Bosco M, Vizzari G, Carciotto G, Maiellaro F, Mangione R, Calderone D, Borgi M, Leoncini M, Tomassini F, Rolfo C, Pavani M, Franze A, Zanda G, Zecchino S, La Manna A, Galassi A, Varbella F. Minicrush or T-Stenting and Minimal Protrusion in Complex Coronary Bifurcation Lesions: The Multicenter TREX Registry. Circ Cardiovasc Interv. 2026 Sep 14:e016666. doi: 10.1161/CIRCINTERVENTIONS.126.016666. Online ahead of print.
PubMed 42734069
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation: Insights From TREX Registry
- ClinicalTrials.gov ID
- NCT06484647
- Acronym / sponsor ID
- 001-2024
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease, Chronic Coronary Syndrome, Acute Coronary Syndrome
- Keywords
- Percutaneous Coronary Intervention (PCI), Coronary Artery Disease (CAD), Coronary Bifurcation Lesion (CBL)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- San Luigi Gonzaga HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
Nowadays, no studies compare the T-stenting And Minimal Protrusion (TAP) and External Minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.
Detailed description
- According to DEFINITION criteria, PCI of the complex coronary bifurcation with up-front two stent techniques is associated with lower target vessel revascularization (TVR) compared to Provisional Stenting
- The Double-Kissing Crush stenting (DK-Crush) has been tested with the Culotte and the Classic Crush techniques in the unprotected left main disease (ULMD) and in no-ULMD setting, respectively, showing better clinical outcomes.
- However, due to its technical complexity and simultaneous improvement of the Classic Crush technique evolving in the External Minicrush, it has meant that the latter has become the most used technique in the clinical practice in treating complex coronary bifurcation
- The DK-Crush technique has never been tested with the External Minicrush, leaving the operators to choose one or the other according to their experience and preferences.
- The T-stenting And Minimal Protrusion (TAP) is a two-stent technique described to treat coronary bifurcation after provisional treating. Compared to crush techniques, it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting.
- Nowadays, no studies compare theTAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.
- The issue's importance is highlighted by higher rates of stent thrombosis (ST) and in-stent restenosis (ISR) of the two stent techniques compared to Provisional Stenting in treating coronary bifurcation8.
- Consequently, investigating the efficacy and safety differences between the techniques could improve the treatment of complex coronary bifurcation to reduce post-PCI TLR.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-stenting And Minimal Protrusion | – | Procedure: Percutaneous Coronary InterventionPercutaneous coronary intervention is performing according to current coronary Revascularization guidelines (ACC/ESC). The vascular access is chosing according patients characteristics and operator preferences and require radial or femoral insertion of the sheath. Antiplatelets strategy is a discretion of the operator and is depending on clinical presentation of the patients and respect the current guidelines (i.e Clopidogrel 600 mg load dose following 75 mg/daily, Ticagrelor 180 mg load dose following 180 mg/daily, Prasugrel 60 mg load dose following 10 mg/daily). The procedural steps of the technique are described below: * MV stenting * Distal rewiring towards SB * Kissing Balloon for opening distal struts towards SB * SB stent implantation * Final Kissing Balloon |
| External Minicrush | – | Procedure: Percutaneous Coronary InterventionPercutaneous coronary intervention is performing according to current coronary Revascularization guidelines (ACC/ESC). The vascular access is chosing according patients characteristics and operator preferences and require radial or femoral insertion of the sheath. Antiplatelets strategy is a discretion of the operator and is depending on clinical presentation of the patients and respect the current guidelines (i.e Clopidogrel 600 mg load dose following 75 mg/daily, Ticagrelor 180 mg load dose following 180 mg/daily, Prasugrel 60 mg load dose following 10 mg/daily). The procedural steps of the technique are described below: * SB stent deployment with protrusion into MB * Crush the SB stent with a balloon inflating into MB (>0.5 mm of the SB stent) * MB stent deployment * Rewiring * POT * KBI * Final POT technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ACS or CCS patients with complex coronary bifurcation lesions with the indication of PCI.
Key inclusion criteria (3 listed)
- Patients >18 years of age
- Patients with an indication for PCI, including chronic coronary syndrome and acute coronary syndromes (STEMI, NSTEMI, unstable angina)
- Patients with at least one true coronary bifurcation according to the Medina classification 1.1.1, 0.1.1, 1.0.1, 0.0.1
Key exclusion criteria (6 listed)
- Patients who do not want or cannot sign the informed consent for the procedure.
- Patients with severe peripheral vascular disease that limits vascular access to the point of making the procedure unsafe.
- Patients with a life expectancy of <1 year.
- Patients with planned major surgery require prolonged discontinuation of antiplatelet therapy.
- Pregnant women.
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 |
|---|---|---|
| Percutaneous Coronary InterventionPercutaneous coronary intervention is a procedure that require coronary stenosis dilatation with dilatation catheter balloon and generally stent implantation. The study involve coronary stenosis at bifurcation level that require complex coronary techniques such as External Minicrush or TAP technique. | Procedure or surgery | External Minicrush, T-stenting And Minimal Protrusion |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 5-years
a composite of cardiac death and target vessel-related myocardial infarction (TV-MI), including Q wave, non-Q wave myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)
3 secondary outcomes
Stent thrombosis (ST)
Time frame: 5-years
Intrastent-restenosis (ISR)
Time frame: 5-years
Target Vessel MI (TVMI)
Time frame: 5-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Derived from this study: PubMed 42734069Piedimonte G, Cerrato E, Azzalini L, Quiros A, Di Fonzo R, Maffi V, Bosco M, Vizzari G, Carciotto G, Maiellaro F, Mangione R, Calderone D, Borgi M, Leoncini M, Tomassini F, Rolfo C, Pavani M, Franze A, Zanda G, Zecchino S, La Manna A, Galassi A, Varbella F. Minicrush or T-Stenting and Minimal Protrusion in Complex Coronary Bifurcation Lesions: The Multicenter TREX Registry. Circ Cardiovasc Interv. 2026 Sep 14:e016666. doi: 10.1161/CIRCINTERVENTIONS.126.016666. Online ahead of print.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by San Luigi Gonzaga Hospital 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?
The sponsor lists 3 inclusion and 6 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 8 Jul 2024. 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 Giulio Piedimonte, MD (+393201764900, giulio.piedimonte@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 5-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06484647, which also lists 1 linked publication.
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 Jul 2024.