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

NCT03939468 | Unknown DMC

• 1 other identifier: HYPER v3
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Drug Coated Balloons; Drug Eluting Stent; Diffuse Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Procedural Success

  At procedure

• Peri-procedural myocardial infarction

  Pre-discharge

• DOCE

  Pre-discharge, 30 days, 6 months, 12 months

• Thrombosis

  12 months

• Flow-limiting dissection

  12 months

Study Arms (1)

Observational Cohort

Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)

Device: DES+DCB

Interventions

DES+DCB DEVICE

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

Observational Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (6)

Presidio Ospedaliero di Rho

Rho, Milano, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Location

Istituto Clinico S.Anna

Brescia, Italy

Location

ASST Ospedale Cremona

Cremona, Italy

Location

Istituto Clinico S.Ambrogio

Milan, Italy

Location

Policlinico Casilino

Roma, Italy

Location

Related Publications (5)

• 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.

  PMID: 24262615 BACKGROUND

• 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.

  PMID: 27056119 BACKGROUND

• 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.

  PMID: 30522667 BACKGROUND

• 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.

  PMID: 32933874 BACKGROUND

• Buono A, Pellicano M, Regazzoli D, Donahue M, Tedeschi D, Loffi M, Zimbardo G, Reimers B, Danzi G, DE Blasio G, Tespili M, Ielasi A. Procedural and one-year outcomes following drug-eluting stent and drug-coated balloon combination for the treatment of de novo diffuse coronary artery disease: the HYPER Study. Minerva Cardiol Angiol. 2024 Apr;72(2):163-171. doi: 10.23736/S2724-5683.23.06352-4. Epub 2023 Sep 13.

  PMID: 37705369 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: October 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

IT (6)