Comparison of Results Achieved by Different Ballooning Techniques in Bifurcation Stenting

Ischemic Heart Disease Clinical Trial

— CRABBIS  

Official title:

Head-to-head Comparison of Stent Geometry Obtained by Different Ballooning Techniques in Large Bifurcations Treated by Provisional Stenting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05559424
• Other study ID #: ID 5053
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: July 2023

Study information

• Verified date: October 2022
• Source: Catholic University of the Sacred Heart
• Contact: Francesco Burzotta, MD, PhD
• Phone: +390650156622
• Email: francesco.burzotta[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• OCT
OCT will be used to assess results after intervention

Locations

Country	Name	City	State
Italy	Policlinico A. Gemelli. Università Cattolica del Sacro Cuore	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent expansion	Minimum stent expansion	Intra-procedural
Secondary	Side branch ostial scaffolding length	difference between maximal stent diameter at bifurcation core and distal reference diameter	Intra-procedural
Secondary	Stent eccentricity index	SEI = minimum stent diameter/maximum stent diameter	Intra-procedural
Secondary	Stent complications	Stent under-expansion	Intra-procedural
Secondary	Additional treatment after OCT	need of additional treatment after assessment of results by OCT	Intra-procedural
Secondary	Stent malapposition	Stent malapposition	Intra-procedural
Secondary	Stent proximal edge dissection	Stent proximal edge dissection	Intra-procedural
Secondary	Tissue prolapse	Tissue prolapse	Intra-procedural
Secondary	Intracoronary thrombus	Intracoronary thrombus	Intra-procedural
Secondary	Side branch ostium dissection	Side branch ostium dissection	Intra-procedural
Secondary	Stent complicatons	In-stent dissection	Intra-procedural