Clinical trial NCT05788432: Sequent Extended Study
Official title: Sequent Please Neo Extended Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Keywords: MDR (Medical Device Regulations)
PMCF (Post-Market Clinical Follow-up)
Paclitaxel eluting coronary balloon dilatation catheter
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Sequent Please Neo according to routine hospital practice and following instructions for use.

Brief summary: Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Sequent Please Neo to meet EU Medical Device regulation (MDR) requirements in all the consecutive patients treated with Sequent Please Neo.

Detailed description: The objective of this multicenter, prospective, non-randomized, postmarket clinical follow-up(PMCF) study is to confirm and support the clinical safety and performance of the Sequent Please Neo in a NON-SELECTED, Real Word population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device Regulation requirements for post-market clinical follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients treated with Sequent please neo according to routine hospital practice and following instruction for use.
* Informed Consent Signed.

Exclusion Criteria:

* Patient life expectancy less than 12 months.
* Contraindication for antiplatelet therapy.
* Not meet inclusion criteria.

Primary outcomes:
measure: Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events)
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from MACE in the subgroup of Lesions In-stent Restenosis
timeFrame: 12 months
measure: Freedom from MACE in the subgroup of Native vessel lesions
timeFrame: 12 months
measure: Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches
timeFrame: 12 months
measure: Procedural success
timeFrame: Immediately after PCI (Percutaneous Coronary Intervention)
Other outcomes:
Locations:
city: Alava
country: Spain
facility: Hospital Universitario de Araba
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante Dr.Balmis
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
city: Baracaldo
country: Spain
facility: Hospital Universitario de Cruces
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu Y Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta Del Mar
city: Ciudad Real
country: Spain
facility: Hospital Universitario de Ciudad Real
city: Cáceres
country: Spain
facility: Hospital Universitario San Pedro de Alcantara
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Gerona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: Jaén
country: Spain
facility: Hospital Universitario de Jaen
city: León
country: Spain
facility: Hospital Universitario de Leon
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Agusti
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de La Victoria
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Mérida
country: Spain
facility: Hospital de Mérida
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Toledo
country: Spain
facility: Hospital General Universitario de Toledo
Study officials:
References:
citation: Rissanen TT, Uskela S, Eranen J, Mantyla P, Olli A, Romppanen H, Siljander A, Pietila M, Minkkinen MJ, Tervo J, Karkkainen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019 Jul 20;394(10194):230-239. doi: 10.1016/S0140-6736(19)31126-2. Epub 2019 Jun 13.
citation: Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
citation: Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia del Blanco B, Garcia-Touchard A, Lopez-Minguez JR, Benedicto A, Masotti M, Zueco J, Iniguez A, Velazquez M, Moreno R, Mainar V, Dominguez A, Pomar F, Melgares R, Rivero F, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C; RIBS IV Study Investigators (under auspices of Interventional Cardiology Working Group of Spanish Society of Cardiology). A Prospective Randomized Trial of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis of Drug-Eluting Stents: The RIBS IV Randomized Clinical Trial. J Am Coll Cardiol. 2015 Jul 7;66(1):23-33. doi: 10.1016/j.jacc.2015.04.063.
citation: Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.
citation: Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2010 Mar;99(3):165-74. doi: 10.1007/s00392-009-0101-6. Epub 2010 Jan 6.