Comparison of Results Achieved by Different Ballooning Techniques in Bifurcation Stenting

NCT05559424 | Unknown

• 1 other identifier: ID 5053
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Ischemic Heart Disease

Keywords

Provisional; OCT; kissing balloon; bifurcations

Outcome Measures

Primary Outcomes (1)

• Stent expansion

  Minimum stent expansion

  Intra-procedural

Secondary Outcomes (10)

• Side branch ostial scaffolding length

  Intra-procedural

• Stent eccentricity index

  Intra-procedural

• Stent complications

  Intra-procedural

• Additional treatment after OCT

  Intra-procedural

• Stent malapposition

  Intra-procedural

Study Arms (2)

POT/KISSING/POT (PKP)

ACTIVE COMPARATOR

* 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

POT/SIDE/POT (PSP)

ACTIVE COMPARATOR

* 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

Interventions

OCT DIAGNOSTIC_TEST

OCT will be used to assess results after intervention

POT/KISSING/POT (PKP); POT/SIDE/POT (PSP)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \- 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)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Policlinico A. Gemelli. Università Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Francesco Burzotta, MD, PhD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Burzotta, MD, PhD

CONTACT

+390650156622; francesco.burzotta@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: October 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)