Treatment of Coronary Bifurcation Lesions: Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting

Coronary Artery Disease Clinical Trial

— TIPTAP-I  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03714750
• Other study ID #: TIP TAP I
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: April 1, 2024

Study information

• Verified date: August 2022
• Source: Johannes Gutenberg University Mainz
• Contact: Tommaso Gori, Prof Dr, PhD
• Phone: +49 (0) 6131 17 2729
• Email: tommaso.gori[@]unimedizin-mainz.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• DK crush
revascularization of true coronary bifurcation stenosis in DK crush technique
• Reverse TAP
revascularization of true coronary bifurcation stenosis in Reverse TAP technique

Locations

Country	Name	City	State
Germany	Center of Cardiology, Cardiology I, university hospital Mainz	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Tommaso Gori

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	average stent eccentricity index (SEI) in the side branch	optical coherence tomography endpoint, calculated as the Ratio of the Minimum to Maximum stent Diameter in the side branch	through study completion, an average of 2 hours
Other	average stent eccentricity index (SEI) in the main branch	optical coherence tomography endpoint, calculated as the Ratio of the Minimum to Maximum stent Diameter in the main branch	through study completion, an average of 2 hours
Other	Minimum lumen diameter in the main branch	optical coherence tomography endpoint, Minimum lumen Diameter in the main branch	through study completion, an average of 2 hours
Other	Mean lumen diameter in the main branch	optical coherence tomography endpoint, Mean lumen Diameter in the main branch	through study completion, an average of 2 hours
Other	Minimum lumen area in the main branch	optical coherence tomography endpoint, Minimum lumen Area in the main branch	through study completion, an average of 2 hours
Other	Mean lumen area in the main branch	optical coherence tomography endpoint, Mean lumen Area in the main branch	through study completion, an average of 2 hours
Other	Minimum lumen diameter in the side branch	optical coherence tomography endpoint, Minimum lumen Diameter in the side branch	through study completion, an average of 2 hours
Other	Mean lumen diameter in the side branch	optical coherence tomography endpoint, Mean lumen Diameter in the side branch	through study completion, an average of 2 hours
Other	Minimum lumen area in the side branch	optical coherence tomography endpoint, Minimum lumen area in the side branch	through study completion, an average of 2 hours
Other	Mean lumen area in the side branch	optical coherence tomography endpoint, Mean lumen Area in the side branch	through study completion, an average of 2 hours
Other	Side branch obstruction	optical coherence tomography endpoint, side branch obstruction through malapposed struts expressed as mean ratio between maximum inter-strut opening and side branch ostium diameter	through study completion, an average of 2 hours
Other	Strut malapposition at bifurcation	optical coherence tomography endpoint, % struts malapposed	through study completion, an average of 2 hours
Primary	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	through study completion, an average of 2 hours
Secondary	fluoroscopy time	Time of radiation during intervention	through study completion, an average of 2 hours
Secondary	procedural time	time of procedure ("Skin-to-Skin"-time)	through study completion, an average of 2 hours
Secondary	use of coronary wires	amount of coronary wires used during procedure	through study completion, an average of 2 hours
Secondary	protocol success	the Intervention is performed according to the protocol (including final kissing PTCA)	through study completion, an average of 2 hours
Secondary	Min. lumen Diameter in main branch	Minimum lumen Diameter in the main branch	through study completion, an average of 2 hours
Secondary	Percentage of Stenosis in main branch	Percentage of Stenosis in the main branch	through study completion, an average of 2 hours
Secondary	Min. lumen Diameter in side branch	Minimum lumen Diameter in the side branch	through study completion, an average of 2 hours
Secondary	Percentage of Stenosis in side branch	Percentage of Stenosis in the side branch	through study completion, an average of 2 hours
Secondary	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	through study completion, an average of 2 days