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

NCT ID: NCT05650450

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2025-01-01

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

Detailed Description

This is a prospective, non-randomized, single-arm, multi-center study aiming 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 (Coronary Artery Disease) encountered in daily clinical practice (lesion length > 38 mm). 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

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

DES+DCB

Intervention Type: 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)

Interventions

DES+DCB

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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Clinico S.Ambrogio

Milan, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 32933874 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27056119 (View on PubMed)

Other Identifiers

HYPER II

Identifier Type: -

Identifier Source: org_study_id