Sequent Extended Study

Coronary Artery Disease Clinical Trial

— rEpic06  

Official title:

Sequent Please Neo Extended Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788432
• Other study ID #: rEpic06- SEQUENT EXTENDED
• Status: Recruiting
• Start date: March 28, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: May 2024
• Source: Fundación EPIC
• Contact: ORIOL RODRIGUEZ LEOR, MD, PhD
• Phone: 0034934651200
• Email: oriolrodriguez[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario de Araba	Alava
Spain	Hospital General Universitario de Alicante Dr.Balmis	Alicante
Spain	Hospital Universitario de Badajoz	Badajoz
Spain	Hospital Universitari Germans Trias I Pujol	Badalona
Spain	Hospital Universitario de Cruces	Baracaldo
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario San Pedro de Alcantara	Cáceres
Spain	Hospital Universitario Puerta Del Mar	Cadiz
Spain	Hospital Universitario de Ciudad Real	Ciudad Real
Spain	Hospital Universitari Dr. Josep Trueta	Gerona
Spain	Hospital Universitario Juan Ramon Jimenez	Huelva
Spain	Hospital Universitario de Jaen	Jaén
Spain	Hospital Universitario de Leon	León
Spain	Hospital Universitario Lucus Agusti	Lugo
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Virgen de La Victoria	Malaga
Spain	Hospital Regional Universitario de Malaga	Málaga
Spain	Hospital de Mérida	Mérida
Spain	Hospital Clinico Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Virgen Del Rocio	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View 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. Erratum In: Lancet. 2019 Jul 20;394(10194):218. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Freedom from MACE in the subgroup of Lesions In-stent Restenosis	Freedom from MACE in the subgroup of Lesions In-stent Restenosis	12 months
Secondary	Freedom from MACE in the subgroup of Native vessel lesions	Freedom from MACE in the subgroup of Native vessel lesions	12 months
Secondary	Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches	Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches	12 months
Secondary	Procedural success	Procedural success ( Residual stenosis <30% and absence of dissection and TIMI ( Thrombolysis in Myocardial Infarction) flow 3 after procedure)	Immediately after PCI (Percutaneous Coronary Intervention)