Coronary Artery DiseaserEpic06NCT05788432
Sequent Extended Study
An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Fundación EPIC at 27 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease
- What is being tested?
- Sequent Please Neo
- Type of treatment
- Medical device
- How many people
- 2,040 participants
- Where
- 27 sitesSpain
- Study dates
- 28 Mar 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with Sequent Please Neo according to routine hospital practice and following instructions for use.
Who may be able to join
- Patients treated with Sequent please neo according to routine hospital practice and following instruction for use.
- Informed Consent Signed.
Who cannot join
- Patient life expectancy less than 12 months.
- Contraindication for antiplatelet therapy.
- Not meet inclusion criteria.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Spain27 sites
Hospital Universitario de Araba
Alava, 01009
Hospital General Universitario de Alicante Dr.Balmis
Alicante, 03010
Hospital Universitario de Badajoz
Badajoz, 06080
Hospital Universitari Germans Trias I Pujol
Badalona, 08916
Hospital Universitario de Cruces
Barakaldo, 48903
Hospital de La Santa Creu Y Sant Pau
Barcelona, 08025
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario San Pedro de Alcantara
Cáceres, 10003
Hospital Universitario Puerta Del Mar
Cadiz, 11009
Hospital General Universitari de Castelló
Castelló, 12004
Hospital Universitario de Ciudad Real
Ciudad Real, 13005
Hospital General Universitario de Elche
Elche, 03203
Hospital Universitario de Cabueñes
Gijón, 33394
Hospital Universitari Dr. Josep Trueta
Girona, 17007
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005
Hospital Universitario de Jaen
Jaén, 23007
Hospital Universitario de Leon
León, 240801
Hospital Universitario Lucus Agusti
Lugo, 27003
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Regional Universitario de Malaga
Málaga, 29010
Hospital Universitario Virgen de La Victoria
Málaga, 29010
Hospital de Mérida
Mérida, 06800
Hospital Universitario Puerto Real
Puerto Real, 11510
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital General Universitario de Toledo
Toledo, 45007
About this study
Official title: Sequent Please Neo Extended Post-Market Clinical Follow-up Study
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease
- Being tested
- Sequent Please Neo
- Keywords
- MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Paclitaxel eluting coronary balloon dilatation catheter
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequent Please NeoDevice
Patients in whom treatment with (Sequent Please Neo) has been attempted
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease (CAD) | Not described Receives: Device: Sequent Please Neo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events)
Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR)
Measured: 12 months
Secondary outcomes (4)
Freedom from MACE in the subgroup of Lesions In-stent Restenosis
Freedom from MACE in the subgroup of Lesions In-stent Restenosis
Measured: 12 months
Freedom from MACE in the subgroup of Native vessel lesions
Freedom from MACE in the subgroup of Native vessel lesions
Measured: 12 months
Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches
Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches
Measured: 12 months
Procedural success
Procedural success ( Residual stenosis <30% and absence of dissection and TIMI ( Thrombolysis in Myocardial Infarction) flow 3 after procedure)
Measured: Immediately after PCI (Percutaneous Coronary Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start28 Mar 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788432
- Sponsor's protocol ID
- rEpic06- SEQUENT EXTENDED
- Acronym
- rEpic06
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2023
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31204115Jeger 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.
PubMed 30170854Alfonso 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.
PubMed 26139054Scheller 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.
PubMed 17101615Unverdorben 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.
PubMed 20052480
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequent Please Neo Extended Post-Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT05788432
- Acronym / sponsor ID
- rEpic06 / rEpic06- SEQUENT EXTENDED
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease
- Keywords
- MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Paclitaxel eluting coronary balloon dilatation catheter
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,040 participants (actual)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease (CAD) | – | Device: Sequent Please Neo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with Sequent Please Neo according to routine hospital practice and following instructions for use.
Key inclusion criteria (2 listed)
- Patients treated with Sequent please neo according to routine hospital practice and following instruction for use.
- Informed Consent Signed.
Key exclusion criteria (3 listed)
- Patient life expectancy less than 12 months.
- Contraindication for antiplatelet therapy.
- Not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequent Please NeoPatients in whom treatment with (Sequent Please Neo) has been attempted | Device | Coronary Artery Disease (CAD) |
Primary outcome
Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events)
Time frame: 12 months
Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR)
4 secondary outcomes
Freedom from MACE in the subgroup of Lesions In-stent Restenosis
Time frame: 12 months
Freedom from MACE in the subgroup of Native vessel lesions
Time frame: 12 months
Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches
Time frame: 12 months
Procedural success
Time frame: Immediately after PCI (Percutaneous Coronary Intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 31204115Rissanen 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.
- Background: PubMed 30170854Jeger 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.
- Background: PubMed 26139054Alfonso 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.
- Background: PubMed 17101615Scheller 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.
- Background: PubMed 20052480Unverdorben 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Fundación EPIC at 27 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05788432, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.