Coronary Artery DiseaseTIPTAP-INCT03714750
Treatment of Coronary Bifurcation Lesions: Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting
A study testing DK crush and Reverse TAP in people with Coronary Artery Disease, run by Tommaso Gori at 1 site in Germany.
Trial summary
Treatment of bifurcation coronary lesions may be challenging, and the best technique to be used in these settings remains to be established. While a single stent strategy is simpler and has been often encouraged, a number of studies show that the use of modern stent implantation techniques may bring some advantages in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- DK crush and Reverse TAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 30 Oct 2018to 1 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the inclusion criteria:
- Documented heart team (as per guidelines) decision for revascularization via PCI
- Planned percutaneous coronary intervention (PCI) for a bifurcation stenosis with both branches >2.5mm and with a stenosis >50% and clinical indication to percutaneous intervention, including:
- Ischemic symptoms, OR
- Positive non-invasive imaging for ischemia, OR
- Positive Flow Fractional Reserve (FFR), OR
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- mean lumen area (MLA) <6mm^2 for the left main or <4mm^2 for epicardial vessels as assessed by intracoronary imaging (IVUS, OCT)
- Vessel diameter ≤5.00mm
- True bifurcation lesion type 1,1,1 or 0,1,1
- Patient ≥18 years old
Who cannot join
- Cardiogenic shock
- Trifurcation if all vessels are ≥2.75mm diameter
- Either bifurcation vessel not suitable for stenting
- History of stenting in target bifurcation lesion
- Participation in another investigational drug or device study
- Patient unable to give informed consent
- Women of child-bearing potential or lactating
- In-stent restenosis
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center of Cardiology, Cardiology I, university hospital Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Treatment of Coronary Bifurcation Lesions: a Non-inferiority, Randomized, Controlled Procedural Outcomes Trial Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting
Treatment of bifurcation coronary lesions may be challenging, and the best technique to be used in these settings remains to be established. While a single stent strategy is simpler and has been often encouraged, a number of studies show that the use of modern stent implantation techniques may bring some advantages in terms of target lesion failure during longer follow-up. Further, single-stent procedures are not possible at all in some settings, for instance when both main and side branch have similar diameters and present both relevant disease, particularly when the angle between the vessels is lower than 70°. Recent randomized data demonstrate the superiority of the technique called double kissing and crush (DK-Crush) over provisional stenting in this setting. The DK-Crush technique is however cumbersome, time-consuming and requires very experienced operators. The investigators therefore plan to undertake a randomized study comparing a novel interventional technique against DK-crush in the setting of true bifurcation lesions (Medina lesions type 1,1,1 or 0,1,1).
- Conditions
- Coronary Artery Disease
- Being tested
- DK crush, Reverse TAP
- Keywords
- bifurcation coronary lesions, interventional technique of coronary lesions, Double kissing and crush, DK crush, Reverse TAP, reverse T-and-protrusion
- Medical subject headings
- Coronary Artery Disease, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DK crushProcedure or surgery
revascularization of true coronary bifurcation stenosis in DK crush technique
Reverse TAPProcedure or surgery
revascularization of true coronary bifurcation stenosis in Reverse TAP technique
| Study group | Role | What they receive |
|---|---|---|
| DK crush | Active comparator | Percutaneous revascularization of true coronary bifurcation stenosis (Medina 1,1,1 or 0,1,1) with double kissing and crush technique Receives: Procedure: DK crush |
| Reverse TAP | Experimental | Percutaneous revascularization of true coronary bifurcation Stenosis (Medina 1,1,1 or 0,1,1) with reverse T and protrusion technique Receives: Procedure: Reverse TAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent Expansion in the side branch (defined as the vessel which received the first stent)
Ratio of the minimum stent area of the side branch and the maximum stent area of the side branch
Measured: through study completion, an average of 2 hours
Secondary outcomes (9)
fluoroscopy time
Time of radiation during intervention
Measured: through study completion, an average of 2 hours
procedural time
time of procedure ("Skin-to-Skin"-time)
Measured: through study completion, an average of 2 hours
use of coronary wires
amount of coronary wires used during procedure
Measured: through study completion, an average of 2 hours
protocol success
the Intervention is performed according to the protocol (including final kissing PTCA)
Measured: through study completion, an average of 2 hours
Min. lumen Diameter in main branch
Minimum lumen Diameter in the main branch
Measured: through study completion, an average of 2 hours
Percentage of Stenosis in main branch
Percentage of Stenosis in the main branch
Measured: through study completion, an average of 2 hours
Min. lumen Diameter in side branch
Minimum lumen Diameter in the side branch
Measured: through study completion, an average of 2 hours
Percentage of Stenosis in side branch
Percentage of Stenosis in the side branch
Measured: through study completion, an average of 2 hours
Procedural success
procedural success defined by angiographic success (no residual Stenosis of more than 20% at the end of Radiation) AND no periprocedural complications (including STEMI, new Q-wave myocardial infarction (MI), death, stent thrombosis, by-pass surgery, peri-procedural cardiac biomarker release according to the third universal definition of myocardial infarction) at discharge
Measured: through study completion, an average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start30 Oct 2018
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tommaso Gori
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tommaso Gori, Johannes Gutenberg University Mainz
- Investigators
- Tommaso Gori, Prof Dr, PhD, Principal investigator, Center of Cardiology, Cardiology I, University hospital Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714750
- Sponsor's protocol ID
- TIP TAP I
- Acronym
- TIPTAP-I
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2018
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abouelnour AE, Olschewski M, Makmur G, Ullrich H, Knorr M, Ahoopai M, Munzel T, Gori T. Six-months clinical and intracoronary imaging follow-up after reverse T and protrusion or double-kissing and crush stenting for the treatment of complex left main bifurcation lesions. Front Cardiovasc Med. 2023 Apr 27;10:1153652. doi: 10.3389/fcvm.2023.1153652. eCollection 2023.
PubMed 37180808Olschewski M, Ullrich H, Knorr M, Makmur G, Ahoopai M, Munzel T, Gori T. Randomized non-inferiority TrIal comParing reverse T And Protrusion versus double-kissing and crush Stenting for the treatment of complex left main bifurcation lesions. Clin Res Cardiol. 2022 Jul;111(7):750-760. doi: 10.1007/s00392-021-01972-2. Epub 2021 Nov 24.
PubMed 34816311Rakhimov K, Buono A, Anadol R, Ullrich H, Knorr M, Ahoopai M, Munzel T, Gori T. Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial. BMJ Open. 2020 Jun 16;10(6):e034264. doi: 10.1136/bmjopen-2019-034264.
PubMed 32554736
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Coronary Bifurcation Lesions: a Non-inferiority, Randomized, Controlled Procedural Outcomes Trial Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting
- ClinicalTrials.gov ID
- NCT03714750
- Acronym / sponsor ID
- TIPTAP-I / TIP TAP I
- Conditions
- Coronary Artery Disease
- Keywords
- bifurcation coronary lesions, interventional technique of coronary lesions, Double kissing and crush, DK crush, Reverse TAP, reverse T-and-protrusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tommaso GoriUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 22 Oct 2018 (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.
Treatment of bifurcation coronary lesions may be challenging, and the best technique to be used in these settings remains to be established. While a single stent strategy is simpler and has been often encouraged, a number of studies show that the use of modern stent implantation techniques may bring some advantages in terms of target lesion failure during longer follow-up. Further, single-stent procedures are not possible at all in some settings, for instance when both main and side branch have similar diameters and present both relevant disease, particularly when the angle between the vessels is lower than 70°. Recent randomized data demonstrate the superiority of the technique called double kissing and crush (DK-Crush) over provisional stenting in this setting. The DK-Crush technique is however cumbersome, time-consuming and requires very experienced operators. The investigators therefore plan to undertake a randomized study comparing a novel interventional technique against DK-crush in the setting of true bifurcation lesions (Medina lesions type 1,1,1 or 0,1,1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DK crush | Active comparator | Procedure: DK crushPercutaneous revascularization of true coronary bifurcation stenosis (Medina 1,1,1 or 0,1,1) with double kissing and crush technique |
| Reverse TAP | Experimental | Procedure: Reverse TAPPercutaneous revascularization of true coronary bifurcation Stenosis (Medina 1,1,1 or 0,1,1) with reverse T and protrusion technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Documented heart team (as per guidelines) decision for revascularization via PCI
- Planned percutaneous coronary intervention (PCI) for a bifurcation stenosis with both branches >2.5mm and with a stenosis >50% and clinical indication to percutaneous intervention, including:
- Vessel diameter ≤5.00mm
- True bifurcation lesion type 1,1,1 or 0,1,1
- Patient ≥18 years old
Key exclusion criteria (8 listed)
- Cardiogenic shock
- Trifurcation if all vessels are ≥2.75mm diameter
- Either bifurcation vessel not suitable for stenting
- History of stenting in target bifurcation lesion
- Participation in another investigational drug or device study
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 |
|---|---|---|
| DK crushrevascularization of true coronary bifurcation stenosis in DK crush technique | Procedure or surgery | DK crush |
| Reverse TAPrevascularization of true coronary bifurcation stenosis in Reverse TAP technique | Procedure or surgery | Reverse TAP |
Primary outcome
Stent Expansion in the side branch (defined as the vessel which received the first stent)
Time frame: through study completion, an average of 2 hours
Ratio of the minimum stent area of the side branch and the maximum stent area of the side branch
9 secondary outcomes
fluoroscopy time
Time frame: through study completion, an average of 2 hours
procedural time
Time frame: through study completion, an average of 2 hours
use of coronary wires
Time frame: through study completion, an average of 2 hours
protocol success
Time frame: through study completion, an average of 2 hours
Min. lumen Diameter in main branch
Time frame: through study completion, an average of 2 hours
Percentage of Stenosis in main branch
Time frame: through study completion, an average of 2 hours
Min. lumen Diameter in side branch
Time frame: through study completion, an average of 2 hours
Percentage of Stenosis in side branch
Time frame: through study completion, an average of 2 hours
Procedural success
Time frame: through study completion, an average of 2 days
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 8 Oct 2024.
- Derived from this study: PubMed 37180808Abouelnour AE, Olschewski M, Makmur G, Ullrich H, Knorr M, Ahoopai M, Munzel T, Gori T. Six-months clinical and intracoronary imaging follow-up after reverse T and protrusion or double-kissing and crush stenting for the treatment of complex left main bifurcation lesions. Front Cardiovasc Med. 2023 Apr 27;10:1153652. doi: 10.3389/fcvm.2023.1153652. eCollection 2023.
- Derived from this study: PubMed 34816311Olschewski M, Ullrich H, Knorr M, Makmur G, Ahoopai M, Munzel T, Gori T. Randomized non-inferiority TrIal comParing reverse T And Protrusion versus double-kissing and crush Stenting for the treatment of complex left main bifurcation lesions. Clin Res Cardiol. 2022 Jul;111(7):750-760. doi: 10.1007/s00392-021-01972-2. Epub 2021 Nov 24.
- Derived from this study: PubMed 32554736Rakhimov K, Buono A, Anadol R, Ullrich H, Knorr M, Ahoopai M, Munzel T, Gori T. Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial. BMJ Open. 2020 Jun 16;10(6):e034264. doi: 10.1136/bmjopen-2019-034264.
- Individual participant dataSharing planned: Undecided
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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.
Tommaso Gori, Prof Dr, PhD principal investigator
Center of Cardiology, Cardiology I, University hospital Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DK crush and Reverse TAP in people with Coronary Artery Disease, run by Tommaso Gori at 1 site in Germany.
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 10 inclusion and 8 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 8 Oct 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 Germany. 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?
Stent Expansion in the side branch (defined as the vessel which received the first stent) (time frame: through study completion, an average of 2 hours). 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 NCT03714750, which also lists 3 linked publications.
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 Oct 2024.