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

Primary Purpose

Ischemic Heart Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
OCT
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Provisional, OCT, kissing balloon, bifurcations

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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)

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

Sites / Locations

  • Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

POT/KISSING/POT (PKP)

POT/SIDE/POT (PSP)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Stent expansion
Minimum stent expansion

Secondary Outcome Measures

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

Full Information

First Posted
September 26, 2022
Last Updated
October 16, 2022
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT05559424
Brief Title
Comparison of Results Achieved by Different Ballooning Techniques in Bifurcation Stenting
Acronym
CRABBIS
Official Title
Head-to-head Comparison of Stent Geometry Obtained by Different Ballooning Techniques in Large Bifurcations Treated by Provisional Stenting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
Provisional, OCT, kissing balloon, bifurcations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 model
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
POT/KISSING/POT (PKP)
Arm Type
Active Comparator
Arm Description
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
Arm Title
POT/SIDE/POT (PSP)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
OCT
Intervention Description
OCT will be used to assess results after intervention
Primary Outcome Measure Information:
Title
Stent expansion
Description
Minimum stent expansion
Time Frame
Intra-procedural
Secondary Outcome Measure Information:
Title
Side branch ostial scaffolding length
Description
difference between maximal stent diameter at bifurcation core and distal reference diameter
Time Frame
Intra-procedural
Title
Stent eccentricity index
Description
SEI = minimum stent diameter/maximum stent diameter
Time Frame
Intra-procedural
Title
Stent complications
Description
Stent under-expansion
Time Frame
Intra-procedural
Title
Additional treatment after OCT
Description
need of additional treatment after assessment of results by OCT
Time Frame
Intra-procedural
Title
Stent malapposition
Description
Stent malapposition
Time Frame
Intra-procedural
Title
Stent proximal edge dissection
Description
Stent proximal edge dissection
Time Frame
Intra-procedural
Title
Tissue prolapse
Description
Tissue prolapse
Time Frame
Intra-procedural
Title
Intracoronary thrombus
Description
Intracoronary thrombus
Time Frame
Intra-procedural
Title
Side branch ostium dissection
Description
Side branch ostium dissection
Time Frame
Intra-procedural
Title
Stent complicatons
Description
In-stent dissection
Time Frame
Intra-procedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Burzotta, MD, PhD
Phone
+390650156622
Email
francesco.burzotta@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Burzotta, MD, PhD
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Results Achieved by Different Ballooning Techniques in Bifurcation Stenting

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