rEpic06: Sequent Extended Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Coronary Artery Disease (CAD)
|
Device: Sequent Please Neo
Patients in whom treatment with (Sequent Please Neo) has been attempted
|
Outcome Measures
Primary Outcome Measures
- Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events) [12 months]
Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR)
Secondary Outcome Measures
- Freedom from MACE in the subgroup of Lesions In-stent Restenosis [12 months]
Freedom from MACE in the subgroup of Lesions In-stent Restenosis
- Freedom from MACE in the subgroup of Native vessel lesions [12 months]
Freedom from MACE in the subgroup of Native vessel lesions
- Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches [12 months]
Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches
- Procedural success [Immediately after PCI (Percutaneous Coronary Intervention)]
Procedural success ( Residual stenosis <30% and absence of dissection and TIMI ( Thrombolysis in Myocardial Infarction) flow 3 after procedure)
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fundación EPIC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- rEpic06- SEQUENT EXTENDED