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

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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: DES+DCB

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 Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy
    • Istituto Clinico S.Anna
  • Cremona, Italy
    • ASST Ospedale Cremona
  • Milano, Italy
    • Istituto Clinico S.Ambrogio
  • Roma, Italy
    • Policlinico Casilino
  • Milano
    • Rho, Milano, Italy
      • Presidio Ospedaliero di Rho
    • Rozzano, Milano, Italy
      • Istituto Clinico Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with stable or unstable CAD eligible for PCI (according to International guidelines) due to diffuse disease (located in the same vessel) suitable for a "hybrid approach" (see below) will be enrolled after signing the informed consent. A hybrid strategy was 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 (located in the smaller distal segment or at a side branch of a bifurcation in the same coronary artery). Diffuse disease is defined as CAD≥28 mm in length involving distal segments or side branches of a bifurcation lesion with a reference vessel diameter (RVD) considered suitable for a hybrid approach in case of ≥2.75 mm RVD for a DEStarget segment and ≥2.0 mm to <2.75 mm RVD for a DCB-target segment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Istituto Clinico Sant'Ambrogio

Publications and helpful links

General Publications

• 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. 2021 Jul;28:14-19. doi: 10.1016/j.carrev.2020.07.036. Epub 2020 Jul 31.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Drug Eluting Stent; Drug Coated Balloons; Diffuse Disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: HYPER v3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No