Sequent Extended Study
rEpic06
Sequent Please Neo Extended Post-Market Clinical Follow-up Study
1 other identifier
observational
2,028
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
Typical duration for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 28, 2023
CompletedStudy Start
First participant enrolled
March 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
April 22, 2026
April 1, 2026
3.2 years
March 13, 2023
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events)
Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR)
12 months
Secondary Outcomes (4)
Freedom from MACE in the subgroup of Lesions In-stent Restenosis
12 months
Freedom from MACE in the subgroup of Native vessel lesions
12 months
Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches
12 months
Procedural success
Immediately after PCI (Percutaneous Coronary Intervention)
Study Arms (1)
Coronary Artery Disease (CAD)
Interventions
Patients in whom treatment with (Sequent Please Neo) has been attempted
Eligibility Criteria
Patients treated with Sequent Please Neo according to routine hospital practice and following instructions for use.
You may qualify if:
- Patients treated with Sequent please neo according to routine hospital practice and following instruction for use.
- Informed Consent Signed.
You may not qualify if:
- Patient life expectancy less than 12 months.
- Contraindication for antiplatelet therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación EPIClead
Study Sites (27)
Hospital Universitario de Araba
Alava, 01009, Spain
Hospital General Universitario de Alicante Dr.Balmis
Alicante, 03010, Spain
Hospital Universitario de Badajoz
Badajoz, 06080, Spain
Hospital Universitari Germans Trias I Pujol
Badalona, 08916, Spain
Hospital Universitario de Cruces
Barakaldo, 48903, Spain
Hospital de La Santa Creu Y Sant Pau
Barcelona, 08025, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Puerta Del Mar
Cadiz, 11009, Spain
Hospital General Universitari de Castelló
Castelló, 12004, Spain
Hospital Universitario San Pedro de Alcantara
Cáceres, 10003, Spain
Hospital Universitario de Ciudad Real
Ciudad Real, 13005, Spain
Hospital General Universitario de Elche
Elche, 03203, Spain
Hospital Universitario de Cabueñes
Gijón, 33394, Spain
Hospital Universitari Dr. Josep Trueta
Girona, 17007, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005, Spain
Hospital Universitario de Jaen
Jaén, 23007, Spain
Hospital Universitario de Leon
León, 240801, Spain
Hospital Universitario Lucus Agusti
Lugo, 27003, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Hospital Universitario Virgen de La Victoria
Málaga, 29010, Spain
Hospital de Mérida
Mérida, 06800, Spain
Hospital Universitario Puerto Real
Puerto Real, 11510, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital General Universitario de Toledo
Toledo, 45007, Spain
Related Publications (5)
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.
PMID: 31204115BACKGROUNDJeger 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.
PMID: 30170854BACKGROUNDAlfonso 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.
PMID: 26139054BACKGROUNDScheller 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.
PMID: 17101615BACKGROUNDUnverdorben 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.
PMID: 20052480BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2023
First Posted
March 28, 2023
Study Start
March 28, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
April 22, 2026
Record last verified: 2026-04