Comparison of Results Achieved by Different Ballooning Techniques in Bifurcation Stenting (CRABBIS)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Diagnostic test: OCT

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesco Burzotta, MD, PhD; Phone Number: +390650156622; Email: francesco.burzotta@gmail.com

Study Locations

• Italy
  • Rome, Italy, 00168
    • Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: POT/KISSING/POT (PKP); SB rewiring is performed with the objective to cross "distal" stent struts (distal rewiring) through pullback technique.; KBI is performed using short non-compliant balloons (balloon of MV sized in a 1:1 ratio with distal MV reference diameter and SB balloon sized in a 1:1 ratio with SB reference diameter), with sequential followed by simultaneous inflation.; Final POT is performed at the same way as initial POT	Diagnostic test: OCT; OCT will be used to assess results after intervention
Active Comparator: POT/SIDE/POT (PSP); SB rewiring is performed with the objective to cross "distal" stent struts (distal rewiring) through pullback technique.; SB dilatation is performed with a balloon sized 1:1 according to SB reference diameter.; Final POT is performed at the same way as initial POT.	Diagnostic test: OCT; OCT will be used to assess results after intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent expansion	Minimum stent expansion	Intra-procedural

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Investigators: Principal Investigator: Francesco Burzotta, MD, PhD, Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: OCT; Provisional; kissing balloon; bifurcations
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: ID 5053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No