Sequent Extended Study

NCT ID: NCT05788432

Last Updated: 2026-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2028 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-28

Study Completion Date

2026-07-01

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Ischemic Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary Artery Disease (CAD)

Sequent Please Neo

Intervention Type DEVICE

Patients in whom treatment with (Sequent Please Neo) has been attempted

Interventions

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Sequent Please Neo

Patients in whom treatment with (Sequent Please Neo) has been attempted

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación EPIC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario de Araba

Alava, , Spain

Site Status RECRUITING

Hospital General Universitario de Alicante Dr.Balmis

Alicante, , Spain

Site Status RECRUITING

Hospital Universitario de Badajoz

Badajoz, , Spain

Site Status RECRUITING

Hospital Universitari Germans Trias I Pujol

Badalona, , Spain

Site Status RECRUITING

Hospital Universitario de Cruces

Barakaldo, , Spain

Site Status RECRUITING

Hospital de La Santa Creu Y Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Puerta Del Mar

Cadiz, , Spain

Site Status RECRUITING

Hospital General Universitari de Castelló

Castelló, , Spain

Site Status RECRUITING

Hospital Universitario San Pedro de Alcantara

Cáceres, , Spain

Site Status RECRUITING

Hospital Universitario de Ciudad Real

Ciudad Real, , Spain

Site Status RECRUITING

Hospital General Universitario de Elche

Elche, , Spain

Site Status RECRUITING

Hospital Universitario de Cabueñes

Gijón, , Spain

Site Status RECRUITING

Hospital Universitari Dr. Josep Trueta

Girona, , Spain

Site Status RECRUITING

Hospital Universitario Juan Ramon Jimenez

Huelva, , Spain

Site Status RECRUITING

Hospital Universitario de Jaen

Jaén, , Spain

Site Status RECRUITING

Hospital Universitario de Leon

León, , Spain

Site Status RECRUITING

Hospital Universitario Lucus Agusti

Lugo, , Spain

Site Status RECRUITING

Hospital Universitario de La Princesa

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Regional Universitario de Malaga

Málaga, , Spain

Site Status RECRUITING

Hospital Universitario Virgen de La Victoria

Málaga, , Spain

Site Status RECRUITING

Hospital de Mérida

Mérida, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Salamanca

Salamanca, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status RECRUITING

Hospital General Universitario de Toledo

Toledo, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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ORIOL RODRIGUEZ LEOR, MD, PhD

Role: CONTACT

0034934651200

FUNDACION EPIC

Role: CONTACT

0034987876135

References

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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.

Reference Type BACKGROUND
PMID: 31204115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30170854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26139054 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17101615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20052480 (View on PubMed)

Other Identifiers

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rEpic06- SEQUENT EXTENDED

Identifier Type: -

Identifier Source: org_study_id

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