Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease

NCT05650450 | Unknown

• 1 other identifier: HYPER II
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

An observational study to evaluate safety and efficacy of the hybrid approach DES/DCB in the treatment of long diffuse de novo coronary artery disease

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• TLF in DES/DCB treated segment at 12 months

  Target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in the DES- and/or the drug-coated balloon (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

• TLF

  Pre-discharge, 30 days, 12 months, 24 months

• Thrombosis

  In-hospital (within 7 days after PCI), at 30-days, 12 months, 24 months follow-up

• Flow-limiting dissection

  At procedure

Study Arms (1)

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

Device: DES+DCB

Interventions

DES+DCB DEVICE

Hybrid approach is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES for a de novo long (\>38 mm) lesion (located in the larger, more proximal part of the vessel -reference vessel diameter -RVD \>2.75 mm-) and DCB inflation for a concomitant and contiguous de novo small vessel disease (distally located with RVD ≤2.75 mm ≥ 2.0 mm)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse long (\>38 mm) CAD involving contiguous segments of the same vessel suitable for a hybrid approach (RVD\>2.75 mm in the proximal DES target segment and RVD ≤2.75 mm ≥ 2.0 mm for the distal DCB target segment). Hybrid approach is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES in the larger, more proximal part of the vessel -reference vessel diameter -RVD \>2.75 mm- and DCB inflation for a concomitant and contiguous de novo small vessel disease - distally located with RVD ≤2.75 mm ≥2.0 mm.

You may qualify if:

• Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse long (\>38 mm) CAD involving contiguous segments of the same vessel suitable for a hybrid approach (RVD\>2.75 mm in the proximal DES target segment and RVD ≤2.75 mm ≥ 2.0 mm for the distal DCB target segment);
• Signed Patient Informed Consent/Data Release Form

You may not qualify if:

• Age \<18 years;
• Cardiogenic shock;
• Pregnancy or breastfeeding;
• Target vessel reference diameter (within planned device deployment segments) \<2.0 or \>5.0 mm;
• Comorbidities with life expectancy \<12 months
• Severe calcification or/tortuosity proximally or at the DCB target segment;
• Prior PCI and stent implantation in the target vessel.

Sponsors & Collaborators

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

Study Sites (1)

Istituto Clinico S.Ambrogio

Milan, Italy

Location

Related Publications (2)

• 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

• 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

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: SPONSOR

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: December 14, 2022
• Study Start: May 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

IT (1)