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

Coronary Artery Disease Clinical Trial

— HYPER  

Official title:

A HYbrid APproach Evaluating A DRug-Coated Balloon in Combination With A New Generation Drug-Eluting Stent in the Treatment of De Novo Diffuse Coronary Artery Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03939468
• Other study ID #: HYPER v3
• Status: Active, not recruiting
• Start date: October 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2021
• Source: Istituto Clinico Sant'Ambrogio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• DES+DCB
A hybrid strategy is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES implantation for a de novo lesion (located in the larger, more proximal part of the vessel) and DCB inflation for a concomitant de novo small vessel disease

Locations

Country	Name	City	State
Italy	Istituto Clinico S.Anna	Brescia
Italy	ASST Ospedale Cremona	Cremona
Italy	Istituto Clinico S.Ambrogio	Milano
Italy	Presidio Ospedaliero di Rho	Rho	Milano
Italy	Policlinico Casilino	Roma
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Sant'Ambrogio

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Costopoulos C, Latib A, Naganuma T, Sticchi A, Figini F, Basavarajaiah S, Carlino M, Chieffo A, Montorfano M, Naim C, Kawaguchi M, Giannini F, Colombo A. The role of drug-eluting balloons alone or in combination with drug-eluting stents in the treatment of de novo diffuse coronary disease. JACC Cardiovasc Interv. 2013 Nov;6(11):1153-9. doi: 10.1016/j.jcin.2013.07.005. — View Citation

Ielasi A, Buono A, Pellicano M, Tedeschi D, Loffi M, Donahue M, Regazzoli D, De Angelis G, Danzi G, Reimers B, Tespili M. A HYbrid APproach evaluating a DRug-coated balloon in combination with a new generation drug-eluting stent in the treatment of de novo diffuse coronary artery disease: The HYPER pilot study. Cardiovasc Revasc Med. 2020 Jul 31. pii: S1553-8389(20)30463-2. doi: 10.1016/j.carrev.2020.07.036. [Epub ahead of print] — View Citation

Ielasi A, Miyazaki T, Geraci S, Testa L, Abdel-Wahab M, Kawamoto H, Ruparelia N, Sato T, Caramanno G, Bedogni F, Tespili M, Colombo A, Latib A. Hybrid strategy with a bioresorbable scaffold and a drug-coated balloon for diffuse coronary artery disease: the "no more metallic cages" multicentre pilot experience. EuroIntervention. 2016 Apr 8;11(14):e1589-95. doi: 10.4244/EIJV11I14A309. — View Citation

Tang Y, Qiao S, Su X, Chen Y, Jin Z, Chen H, Xu B, Kong X, Pang W, Liu Y, Yu Z, Li X, Li H, Zhao Y, Wang Y, Li W, Tian J, Guan C, Xu B, Gao R; RESTORE SVD China Investigators. Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2381-2392. doi: 10.1016/j.jcin.2018.09.009. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DOCE at 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	12 Months
Secondary	Procedural Success	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.	At procedure
Secondary	Peri-procedural myocardial infarction	Peri-procedural myocardial infarction defined as an elevation of cardiac biomarkers (troponin or creatine kinase-myocardial band) >3 times the upper limit of normal	Pre-discharge
Secondary	DOCE	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	Pre-discharge, 30 days, 6 months, 12 months
Secondary	Thrombosis	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).	12 months
Secondary	Flow-limiting dissection	Flow-limiting dissection (type C-F waiting 3 minutes after DCB inflation) requiring additional DES implantation in the DCB-treated segment	12 months