Clinical trial NCT03939468: Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent for de Novo Diffuse Disease Treatment
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Drug Coated Balloons
Drug Eluting Stent
Diffuse Disease
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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

Eligibility criteria: 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;

Primary outcomes:
measure: DOCE at 12 Months
timeFrame: 12 Months
Secondary outcomes:
measure: Procedural Success
timeFrame: At procedure
measure: Peri-procedural myocardial infarction
timeFrame: Pre-discharge
measure: DOCE
timeFrame: Pre-discharge, 30 days, 6 months, 12 months
measure: Thrombosis
timeFrame: 12 months
measure: Flow-limiting dissection
timeFrame: 12 months
Other outcomes:
Locations:
city: Rho
country: Italy
facility: Presidio Ospedaliero di Rho
state: Milano
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Brescia
country: Italy
facility: Istituto Clinico S.Anna
city: Cremona
country: Italy
facility: ASST Ospedale Cremona
city: Milano
country: Italy
facility: Istituto Clinico S.Ambrogio
city: Roma
country: Italy
facility: Policlinico Casilino
Study officials:
References:
citation: 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.
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.
citation: 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.
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.