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

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05559424

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease	Diagnostic Test: OCT	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Before enrollment start, the plausibility of the study hypothesis will be verified in an experimental pilot randomized investigation conducted n an ex-vivo beating heart animal modelBefore enrollment start, the plausibility of the study hypothesis will be verified in an experimental pilot randomized investigation conducted n an ex-vivo beating heart animal model

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Stent expansion [Intra-procedural]
Minimum stent expansion

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)