Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons

Chronic Coronary Syndrome Clinical Trial

— TITAN-DEB  

Official title:

TicIn for the Treatment of coronAry lesioNs With Drug Eluting Balloons

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674630
• Other study ID #: 01_TITAN-DEB
• Status: Recruiting
• Phase: Phase 4
• Start date: February 21, 2023
• Est. completion date: December 1, 2030

Study information

• Verified date: September 2023
• Source: Cardiocentro Ticino
• Contact: Marco Valgimigli, M.D., Ph.D
• Phone: +410918115111
• Email: marco.valgimigli[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 1, 2030
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients (=18 years old) with chronic coronary syndrome deemed suitable for PCI

2. 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

3. Written informed consent

Exclusion Criteria:

1. Patients referred to the index procedure for an acute coronary syndrome

2. Target lesion involving the left main and/or ostial left coronary artery, ostial left circumflex artery or ostial right coronary artery

3. Severe renal impairment (eGFR<15ml/min/1.73m2) or patient on dialysis treatment

4. Spontaneous coronary artery dissection (SCAD)

5. 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)

6. Known pregnancy or breast-feeding patients

7. Life expectancy <1 year due to other severe non-cardiac disease

8. Legally incompetent to provide informed consent

9. Participation in another clinical study with an investigational product

Related Conditions & MeSH terms

• Chronic Coronary Syndrome
• Syndrome

Intervention

Device:
• Magic Touch drug eluting balloon based strategy
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.
• Drug-eluting stent-based strategy
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.

Locations

Country	Name	City	State
Switzerland	Marco Valgimigli	Lugano

Sponsors (2)

Lead Sponsor	Collaborator
Cardiocentro Ticino	University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change of FFR values (?FFR)	Absolute change of fractional flow reserve (FFR) values (?FFR) measured at the final assessment immediately after the index PCI and invasive follow-up at 6(±30days) or 12(±30 days) months	At 6(±30days) or 12(±30 days) months after the index PCI
Secondary	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.	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	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.	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	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.	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	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.	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	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	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	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	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	Minimal lumen diameter (MLD, mm)	Minimal lumen diameter (MLD, mm) evaluated with intravascular ultrasound (IVUS)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	Minimal luminal area (MLA, mm^2)	Minimal luminal area (MLA, mm^2) evaluated with intravascular ultrasound (IVUS)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	Maximal diameter stenosis (MaxS, percent)	Maximal diameter stenosis (MaxS, percent) evaluated with intravascular ultrasound (IVUS)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	Lumen volume (LV, mm^3)	Lumen volume (LV, mm^3) evaluated with intravascular ultrasound (IVUS)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	Vessel volume (VV, mm^3)	Vessel volume (VV, mm^3) evaluated with intravascular ultrasound (IVUS)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	Plaque burden (VV-LV)	Plaque burden (VV-LV) evaluated with intravascular ultrasound (IVUS)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	Late lumen loss (LLL)	Late lumen loss (LLL) evaluated with intravascular ultrasound (IVUS)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	Acute gain	Variation between pre treatment (T0) and immediately after the treatment (Tf)	pre procedure and immediately after the procedure
Secondary	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)	pre procedure, immediately after the procedure and at 6(±30days) or 12(±30 days) months after the index PCI
Secondary	Target lesion revascularization (TLR) defined as urgent and non-urgent	Rate of target lesion revascularization (TLR) defined as urgent and non-urgent	5 years after the index PCI
Secondary	Target vessel revascularization (TVR), defined as urgent and non-urgent	Rate of target vessel revascularization (TVR), defined as urgent and non-urgent	5 years after the index PCI
Secondary	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	5 years after the index PCI
Secondary	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)	5 years after the index PCI
Secondary	Any myocardial infarction	Rate of any myocardial infarction	5 years after the index PCI
Secondary	Stroke	Rate of stroke	5 years after the index PCI
Secondary	Definite or probable stent thrombosis	Rate of definite or probable stent thrombosis	5 years after the index PCI