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NCT Number: NCT03714750

Treatment of Coronary Bifurcation Lesions: 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).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DK crush

Procedure

revascularization of true coronary bifurcation stenosis in DK crush technique

Reverse TAP

Procedure

revascularization of true coronary bifurcation stenosis in Reverse TAP technique

Primary outcomes

  1. 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

Secondary outcomes

  1. fluoroscopy time

    Time frame: through study completion, an average of 2 hours

    Time of radiation during intervention

  2. procedural time

    Time frame: through study completion, an average of 2 hours

    time of procedure ("Skin-to-Skin"-time)

  3. use of coronary wires

    Time frame: through study completion, an average of 2 hours

    amount of coronary wires used during procedure

  4. protocol success

    Time frame: through study completion, an average of 2 hours

    the Intervention is performed according to the protocol (including final kissing PTCA)

  5. Min. lumen Diameter in main branch

    Time frame: through study completion, an average of 2 hours

    Minimum lumen Diameter in the main branch

  6. Percentage of Stenosis in main branch

    Time frame: through study completion, an average of 2 hours

    Percentage of Stenosis in the main branch

  7. Min. lumen Diameter in side branch

    Time frame: through study completion, an average of 2 hours

    Minimum lumen Diameter in the side branch

  8. Percentage of Stenosis in side branch

    Time frame: through study completion, an average of 2 hours

    Percentage of Stenosis in the side branch

  9. Procedural success

    Time frame: through study completion, an average of 2 days

    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

Other outcomes

  1. average stent eccentricity index (SEI) in the side branch

    Time frame: through study completion, an average of 2 hours

    optical coherence tomography endpoint, calculated as the Ratio of the Minimum to Maximum stent Diameter in the side branch

  2. average stent eccentricity index (SEI) in the main branch

    Time frame: through study completion, an average of 2 hours

    optical coherence tomography endpoint, calculated as the Ratio of the Minimum to Maximum stent Diameter in the main branch

  3. Minimum lumen diameter in the main branch

    Time frame: through study completion, an average of 2 hours

    optical coherence tomography endpoint, Minimum lumen Diameter in the main branch

  4. Mean lumen diameter in the main branch

    Time frame: through study completion, an average of 2 hours

    optical coherence tomography endpoint, Mean lumen Diameter in the main branch

  5. Minimum lumen area in the main branch

    Time frame: through study completion, an average of 2 hours

    optical coherence tomography endpoint, Minimum lumen Area in the main branch

  6. Mean lumen area in the main branch

    Time frame: through study completion, an average of 2 hours

    optical coherence tomography endpoint, Mean lumen Area in the main branch

  7. Minimum lumen diameter in the side branch

    Time frame: through study completion, an average of 2 hours

    optical coherence tomography endpoint, Minimum lumen Diameter in the side branch

  8. Mean lumen diameter in the side branch

    Time frame: through study completion, an average of 2 hours

    optical coherence tomography endpoint, Mean lumen Diameter in the side branch

  9. Minimum lumen area in the side branch

    Time frame: through study completion, an average of 2 hours

    optical coherence tomography endpoint, Minimum lumen area in the side branch

  10. Mean lumen area in the side branch

    Time frame: through study completion, an average of 2 hours

    optical coherence tomography endpoint, Mean lumen Area in the side branch

  11. Side branch obstruction

    Time frame: through study completion, an average of 2 hours

    optical coherence tomography endpoint, side branch obstruction through malapposed struts expressed as mean ratio between maximum inter-strut opening and side branch ostium diameter

  12. Strut malapposition at bifurcation

    Time frame: through study completion, an average of 2 hours

    optical coherence tomography endpoint, % struts malapposed

Sponsors and collaborators

Lead sponsor

Tommaso Gori

Other

Registry information

Official study 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

Acronym: TIPTAP-I

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2018
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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