Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent for de Novo Diffuse Disease Treatment

• Conditions: Coronary Artery Disease
• Interventions: Device: DES+DCB

• Registration Number: NCT03939468
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

A Pilot Observational Study to evaluate safety and efficacy of the hybrid approach DES/DCB in treating de-novo diffuse lesions

Detailed Description

This is a prospective, non-randomized, single-arm, multi-center, pilot, noninterventional study whose aim is to assess the feasibility and the clinical outcomes of using the Restore DCB (Cardionovum GmbH, Bonn, Germany) in combination ("hybrid approach") with a new generation DES (type at operator's discretion) for the treatment of diffuse CAD encountered in daily clinical practice. The rationale of the proposed strategy derives from the characteristics of DCB in treating the atherosclerotic disease without leaving a permanent structure in the vessel especially in case of diffuse CAD -avoiding a long metallic, permanent cage within extended coronary segments

Study Timeline

• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Study Start: 2019-10-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse CAD involving segments suitable for a hybrid approach;
• Signed Patient Informed Consent/Data Release Form

Exclusion Criteria

1. Age <18 years;
2. Cardiogenic shock;
3. Pregnancy or breastfeeding;
4. Infarct-artery max diameter (within planned device deployment segment) <2.0 or >5.0 mm;
5. Comorbidities with life expectancy <6 months;
6. Severe calcification or/tortuosity proximally or at the DCB target segment;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Cohort	DES+DCB	Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)

Primary Outcome Measures

Name	Time	Method
DOCE at 12 Months	12 Months	A device oriented composite end-point (DOCE) of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in the DES- and/or the DCB-treated segment within 12 months after the index procedure

Secondary Outcome Measures

Name	Time	Method
Peri-procedural myocardial infarction	Pre-discharge	Peri-procedural myocardial infarction defined as an elevation of cardiac biomarkers (troponin or creatine kinase-myocardial band) \>3 times the upper limit of normal
DOCE	Pre-discharge, 30 days, 6 months, 12 months	DOCE and its singular components (cardiac death, any TV-MI excluding peri-procedural MI, ID-TLR ) in-hospital, (within 7 days after PCI) and at 30-day, 6-month, 1-year follow-up
Thrombosis	12 months	Any definite/probable DES- or DCB-treated segment thrombosis (in-hospital, within 7 days after PCI and at 30-day, 6month, 1-year follow-up).
Procedural Success	At procedure	Procedural success defined as both DCB/DES delivery and implantation at the "target" lesion site with \<30% diameter stenosis (DS) in the DCB-treated segment and \<10% DS in the DES-treated segment and distal TIMI 3 flow.
Flow-limiting dissection	12 months	Flow-limiting dissection (type C-F waiting 3 minutes after DCB inflation) requiring additional DES implantation in the DCB-treated segment

Trial Locations

Locations (6)

Istituto Clinico S.Anna; 🇮🇹 Brescia, Italy

ASST Ospedale Cremona; 🇮🇹 Cremona, Italy

Presidio Ospedaliero di Rho; 🇮🇹 Rho, Milano, Italy

Policlinico Casilino; 🇮🇹 Roma, Italy

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy

Istituto Clinico S.Ambrogio; 🇮🇹 Milano, Italy