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Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons (TITAN-DEB)

Primary Purpose

Chronic Coronary Syndrome

Status

Recruiting

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Magic Touch drug eluting balloon based strategy

Drug-eluting stent-based strategy

About this trial

This is an interventional treatment trial for Chronic Coronary Syndrome focused on measuring adult, chronic coronary syndrome, percutaneous intervention, significant de novo coronary lesion, FFR≤0.80, iFR≤0.89, long DES (≥30 mm), coronary lesion, drug eluting balloon, drug eluting stent, Magic Touch drug eluting balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients (≥18 years old) with chronic coronary syndrome deemed suitable for PCI At least one significant de-novo coronary lesion (defined as diameter stenosis > 50% on angiography, with flow limiting features, confirmed with FFR ≤0.80 or iFR ≤0.89 and intended implantation of a long (≥30 mm) DES based on IVUS findings Written informed consent Exclusion Criteria: Patients referred to the index procedure for an acute coronary syndrome Target lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery Severe renal impairment (eGFR<15ml/min/1.73m2) or patient on dialysis treatment Spontaneous coronary artery dissection (SCAD) Contraindications to adenosine administration (e.g. moderate to severe asthma or chronic obstructive pulmonary disease, heart rate <50 beats/min and systolic blood pressure <90 mmHg) Known pregnancy or breast-feeding patients Life expectancy <1 year due to other severe non-cardiac disease Legally incompetent to provide informed consent Participation in another clinical study with an investigational product

Sites / Locations

Marco ValgimigliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow up

Drug eluting stent based strategy - 6/12 months invasive follow up

Arm Description

Patients randomized to DEB-based strategy will receive treatment with DEB (Magic Touch, Concept Medical®) throughout the entire lesion length, followed by final assessment with FFR and IVUS at 6 or 12 months in a randomized fashion.

Percutaneous transluminal coronary angioplasty and drug eluting stent implantation according to local standard of care, including optimization techniques (e.g. post-dilatation) which are left at operators' discretion, followed by final assessment with FFR and IVUS at 6 or 12 months in a randomized fashion.

Outcomes

Primary Outcome Measures

Absolute change of FFR values (ΔFFR)

Absolute change of fractional flow reserve (FFR) values (ΔFFR) measured at the final assessment immediately after the index PCI and invasive follow-up at 6(±30days) or 12(±30 days) months

Secondary Outcome Measures

QCA parameter (minimal lumen diameter, MLD, mm) before and after the intervention and at follow-up angiography

Minimal lumen diameter (MLD,mm) before the intervention, immediately after the intervention and at follow-up angiography.

QCA parameter (maximal diameter stenosis, MaxS, percent) before and after the intervention and at follow-up angiography

Maximal diameter stenosis (MaxS, percent) before the intervention, immediately after the intervention and at follow-up angiography.

QCA parameter (reference vessel diameter, RVD, mm) before and after the intervention and at follow-up angiography

Reference vessel diameter (RVD, mm) before the intervention, immediately after the intervention and at follow-up angiography.

QCA parameter (lesion length, LL, mm) before and after the intervention and at follow-up angiography.

Lesion length (LL, mm) before the intervention, immediately after the intervention and at follow-up angiography.

QFR parameters before and after intervention and at follow-up angiography

Quantitative Flow Ratio (QFR) parameters before the intervention, immediately after the intervention and at follow-up angiography

FFR parameters before and after intervention and at follow-up angiography

Fractional Flow Reserve (FFR) parameters before the intervention, immediately after the intervention and at follow-up angiography

Minimal lumen diameter (MLD, mm)

Minimal lumen diameter (MLD, mm) evaluated with intravascular ultrasound (IVUS)

Minimal luminal area (MLA, mm^2)

Minimal luminal area (MLA, mm^2) evaluated with intravascular ultrasound (IVUS)

Maximal diameter stenosis (MaxS, percent)

Maximal diameter stenosis (MaxS, percent) evaluated with intravascular ultrasound (IVUS)

Lumen volume (LV, mm^3)

Lumen volume (LV, mm^3) evaluated with intravascular ultrasound (IVUS)

Vessel volume (VV, mm^3)

Vessel volume (VV, mm^3) evaluated with intravascular ultrasound (IVUS)

Plaque burden (VV-LV)

Plaque burden (VV-LV) evaluated with intravascular ultrasound (IVUS)

Late lumen loss (LLL)

Late lumen loss (LLL) evaluated with intravascular ultrasound (IVUS)

Acute gain

Variation between pre treatment (T0) and immediately after the treatment (Tf)

Disease progression after index PCI

Variation between final result of index PCI (Tf) and procedure at 6(±30days) or 12(±30 days) months after the index PCI (Tc)

Target lesion revascularization (TLR) defined as urgent and non-urgent

Rate of target lesion revascularization (TLR) defined as urgent and non-urgent

Target vessel revascularization (TVR), defined as urgent and non-urgent

Rate of target vessel revascularization (TVR), defined as urgent and non-urgent

Target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization

Rate of target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization

The individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)

Rate of the individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)

Any myocardial infarction

Rate of any myocardial infarction

Stroke

Rate of stroke

Definite or probable stent thrombosis

Rate of definite or probable stent thrombosis

Full Information

NCT ID

NCT05674630

First Posted

December 7, 2022

Last Updated

September 6, 2023

Sponsor

Cardiocentro Ticino

Collaborators

University of Bern

1. Study Identification

Unique Protocol Identification Number

NCT05674630

Brief Title

Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

Acronym

TITAN-DEB

Official Title

TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 21, 2023 (Actual)

Primary Completion Date

June 1, 2026 (Anticipated)

Study Completion Date

December 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cardiocentro Ticino

Collaborators

University of Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The goal of this clinical trial is to compare the use of a specific drug eluting balloon (Magic Touch, Concept Medical®) versus standard drug eluting stent based strategies in patients with long coronary lesions. Participants with chronic coronary disease and long coronary stenosis will be randomly assign to be treated either with Magic Touch balloon or drug eluting stent.

Detailed Description

Patients at coronary angiography who are deemed suitable for PCI are assessed for eligibility. Patients fulfilling all inclusion and no exclusion criteria can be consented for trial participation. After successful lesion preparation, defined as residual stenosis less than 30%, TIMI flow 3 and no major (type C) dissection of target lesion, consented patients will be randomized in a 1:1 ratio to a drug eluting balloon(DEB)-based or standard drug eluting stent(DES)-based strategy and further randomized in a 1:1 fashion, stratified based on DEB vs DES, to undergo invasive follow-up at 6 (±30 days) or 12 (±30 days) months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Coronary Syndrome

Keywords

adult, chronic coronary syndrome, percutaneous intervention, significant de novo coronary lesion, FFR≤0.80, iFR≤0.89, long DES (≥30 mm), coronary lesion, drug eluting balloon, drug eluting stent, Magic Touch drug eluting balloon

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Magic Touch drug eluting balloon based strategy - 6/12 months invasive follow up

Arm Type

Experimental

Arm Description

Arm Title

Drug eluting stent based strategy - 6/12 months invasive follow up

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Magic Touch drug eluting balloon based strategy

Intervention Description

Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the experimental arm will receive treatment with drug eluting balloon (Magic Touch®) followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.

Intervention Type

Device

Intervention Name(s)

Drug-eluting stent-based strategy

Intervention Description

Adult patients with chronic coronary syndrome deemed suitable for percutaneous intervention and significant long de-novo coronary lesion randomized in the control arm will receive treatment with drug-eluting stent followed by invasive follow up (FFR and IVUS) at 6 ot 12 months in a randomized fashion.

Primary Outcome Measure Information:

Title

Absolute change of FFR values (ΔFFR)

Description

Absolute change of fractional flow reserve (FFR) values (ΔFFR) measured at the final assessment immediately after the index PCI and invasive follow-up at 6(±30days) or 12(±30 days) months

Time Frame

At 6(±30days) or 12(±30 days) months after the index PCI

Secondary Outcome Measure Information:

Title

QCA parameter (minimal lumen diameter, MLD, mm) before and after the intervention and at follow-up angiography

Description

Minimal lumen diameter (MLD,mm) before the intervention, immediately after the intervention and at follow-up angiography.

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

QCA parameter (maximal diameter stenosis, MaxS, percent) before and after the intervention and at follow-up angiography

Description

Maximal diameter stenosis (MaxS, percent) before the intervention, immediately after the intervention and at follow-up angiography.

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

QCA parameter (reference vessel diameter, RVD, mm) before and after the intervention and at follow-up angiography

Description

Reference vessel diameter (RVD, mm) before the intervention, immediately after the intervention and at follow-up angiography.

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

QCA parameter (lesion length, LL, mm) before and after the intervention and at follow-up angiography.

Description

Lesion length (LL, mm) before the intervention, immediately after the intervention and at follow-up angiography.

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

QFR parameters before and after intervention and at follow-up angiography

Description

Quantitative Flow Ratio (QFR) parameters before the intervention, immediately after the intervention and at follow-up angiography

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

FFR parameters before and after intervention and at follow-up angiography

Description

Fractional Flow Reserve (FFR) parameters before the intervention, immediately after the intervention and at follow-up angiography

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

Minimal lumen diameter (MLD, mm)

Description

Minimal lumen diameter (MLD, mm) evaluated with intravascular ultrasound (IVUS)

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

Minimal luminal area (MLA, mm^2)

Description

Minimal luminal area (MLA, mm^2) evaluated with intravascular ultrasound (IVUS)

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

Maximal diameter stenosis (MaxS, percent)

Description

Maximal diameter stenosis (MaxS, percent) evaluated with intravascular ultrasound (IVUS)

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

Lumen volume (LV, mm^3)

Description

Lumen volume (LV, mm^3) evaluated with intravascular ultrasound (IVUS)

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

Vessel volume (VV, mm^3)

Description

Vessel volume (VV, mm^3) evaluated with intravascular ultrasound (IVUS)

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

Plaque burden (VV-LV)

Description

Plaque burden (VV-LV) evaluated with intravascular ultrasound (IVUS)

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

Late lumen loss (LLL)

Description

Late lumen loss (LLL) evaluated with intravascular ultrasound (IVUS)

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

Acute gain

Description

Variation between pre treatment (T0) and immediately after the treatment (Tf)

Time Frame

pre procedure and immediately after the procedure

Title

Disease progression after index PCI

Description

Variation between final result of index PCI (Tf) and procedure at 6(±30days) or 12(±30 days) months after the index PCI (Tc)

Time Frame

pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI

Title

Target lesion revascularization (TLR) defined as urgent and non-urgent

Description

Rate of target lesion revascularization (TLR) defined as urgent and non-urgent

Time Frame

5 years after the index PCI

Title

Target vessel revascularization (TVR), defined as urgent and non-urgent

Description

Rate of target vessel revascularization (TVR), defined as urgent and non-urgent

Time Frame

5 years after the index PCI

Title

Target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization

Description

Rate of target vessel failure (TVF), defined as cardiac death, target-vessel myocardial infarction, and any target lesion revascularization

Time Frame

5 years after the index PCI

Title

The individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)

Description

Rate of the individual components of the composite target vessel failure (TVF) endpoint (defined as cardiac death, target-vessel myocardial infarction and any target lesion revascularization)

Time Frame

5 years after the index PCI

Title

Any myocardial infarction

Description

Rate of any myocardial infarction

Time Frame

5 years after the index PCI

Title

Stroke

Description

Rate of stroke

Time Frame

5 years after the index PCI

Title

Definite or probable stent thrombosis

Description

Rate of definite or probable stent thrombosis

Time Frame

5 years after the index PCI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marco Valgimigli, M.D., Ph.D

Phone

+410918115111

marco.valgimigli@eoc.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Enrico Frigoli, M.D.

enrico.frigoli@eoc.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marco Valgimigli, M.D., Ph.D

Organizational Affiliation

Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,

Official's Role

Principal Investigator

Facility Information:

Facility Name

Marco Valgimigli

City

Lugano

ZIP/Postal Code

6900

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Enrico Frigoli, MD

Phone

+410918115111

12. IPD Sharing Statement

Learn more about this trial

Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

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