Comparison of Results Achieved by Different Ballooning Techniques in Bifurcation Stenting

Not Applicable

Not yet recruiting

• Conditions: Ischemic Heart Disease
• Interventions: Diagnostic Test: OCT

• Registration Number: NCT05559424
• Lead Sponsor: Catholic University of the Sacred Heart

Brief 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).

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 Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Status Verified: 2022-10
• Study Start: 2022-10
• Last Update Submitted: 2022-10-16
• Last Update Posted: 2022-10-18
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POT/KISSING/POT (PKP)	OCT	* 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
POT/SIDE/POT (PSP)	OCT	* 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.

Primary Outcome Measures

Name	Time	Method
Stent expansion	Intra-procedural	Minimum stent expansion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Policlinico A. Gemelli. Università Cattolica del Sacro Cuore; 🇮🇹 Rome, Italy