Clinical trial NCT05650450: Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease
Official title: A Hybrid Approach Evaluating A Drug-Coated Balloon in Combination With A New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease: The HYPER II Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Coronary Artery Disease
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: TLF in DES/DCB treated segment at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Procedural success
timeFrame: At procedure
measure: Peri-procedural myocardial infarction
timeFrame: Pre-discharge
measure: TLF
timeFrame: Pre-discharge, 30 days, 12 months, 24 months
measure: Thrombosis
timeFrame: In-hospital (within 7 days after PCI), at 30-days, 12 months, 24 months follow-up
measure: Flow-limiting dissection
timeFrame: At procedure
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Clinico S.Ambrogio
Study officials:
References:
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. 2021 Jul;28:14-19. doi: 10.1016/j.carrev.2020.07.036. Epub 2020 Jul 31.
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.