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Coronary Artery DiseaseSCORENCT04470934

SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)

An observational study of Coronary Artery Disease and Myocardial Ischaemia, run by B. Braun Melsungen AG at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The product under investigation will be used in routine clinical practice according to the latest European Society of Cardiology (ESC) guidelines and according to the Instructions for Use (IFU). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, Myocardial Ischaemia
What is being tested?
SeQuent® SCB drug-coated balloon catheter
Type of treatment
Medical device
How many people
1,302 participants
Where
1 siteGermany
Study dates
30 Apr 2021to 31 Mar 2027
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: This is a single-armed, prospective, international, multi-center, post-market study in patients with coronary artery disease and indication for PCI either due to anginal symptoms and a relevant stenotic coronary lesion during angiography or due to documented ischemia by non-invasive or invasive functional testing. All patients who undergo a target intervention with the SCB will be followed for 12 and 24 months after initial PCI.

Who may be able to join

  • All common significant coronary lesions
  • Target lesion length >34mm need to be covered with at least 2 devices
  • Patients eligible for this study must be at least 18 years of age
  • The patient must fulfil the standard recommendations for percutaneous coronary intervention (PCI), based on the last ESC recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment

Who cannot join

  • Intolerance to sirolimus
  • Allergy to components of the coating
  • Pregnancy and lactation
  • Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
  • Cardiogenic shock
  • Risk of an intraluminal thrombus
Show all 15Show fewer
  • Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
  • Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
  • Severe allergy to contrast media
  • Lesions which are untreatable with PCI or other interventional techniques
  • Patients with an ejection fraction of < 30 %
  • Vascular reference diameter < 2.00 mm
  • Treatment of the left stem (first section of the left coronary artery)
  • Indication for a bypass surgery
  • Contraindication for whichever accompanying medication is necessary

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsklinikum Jena

    Jena, Thuringia, 07747

Other trials in Germany

About this study

Official title: PMCF - Study on the Performance/Safety of SeQuent® Sirolimus-Coated Balloon (SCB, Investigational Device) in Patients With Coronary Artery Disease

The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The product under investigation will be used in routine clinical practice according to the latest European Society of Cardiology (ESC) guidelines and according to the Instructions for Use (IFU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).

Read the detailed description

The objective of the study is to assess the continued safety and efficacy of SeQuent® SCB for the treatment of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts. Study goals are based on non-inferiority for Drug-Coated Balloon (DCB) compared to Paclitaxel-Coated Balloon (PCB) and Dru-eluting Stents (DES) (historical data) with 80% power. Primary and secondary outcome variables are international accepted parameters in stent-trials, which sufficiently describe the efficacy and safety of the investigated device and allow clinical conclusions. Additional attention will be paid to those patients who received, by observation, a shortened dual antiplatelet therapy (DAPT).

The aim of the study is to assess the safety and efficacy of the SeQuent® SCB in the treatment of coronary artery disease with reference vessel diameters between ≥ 2 mm and ≤ 4 mm with suitable lesion lengths. There is no limitation of lesion lengths. In case the lesion is longer than 34 mm, more than one stent needs to be used.

Being tested
SeQuent® SCB drug-coated balloon catheter
Keywords
Coronary Artery Disease, Myocardial Ischemia, drug-coated balloon 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® SCB drug-coated balloon catheterDevice

    treatment of coronary artery disease with SeQuent® SCB of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Lesion Failure (TLF)

    Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR).

    Measured: at 12 months

Secondary outcomes (17)

  1. Target Lesion Failure (TLF)

    Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR).

    Measured: at 24 months

  2. ischemia driven target lesion revascularization (TLR)

    Measured: at 12 months

  3. ischemia driven target lesion revascularization (TLR)

    Measured: at 24 months

  4. all-cause death, cardiac death

    Measured: at 12 months

  5. all-cause death, cardiac death

    Measured: at 24 months

  6. all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)

    Measured: at 12 months

  7. all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)

    Measured: at 24 months

  8. major adverse coronary event (MACE)

    major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization

    Measured: at 12 months

  9. major adverse coronary event (MACE)

    major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization

    Measured: at 24 months

  10. Dual Antiplatelet Therapy (DAPT) compliance

    Measured: at 4 weeks

  11. Dual Antiplatelet Therapy (DAPT) compliance

    Measured: at 3 months

  12. Probable or definite stent-thrombosis of In-stent treated lesions

    Measured: accumulated at 12 months

  13. Probable or definite stent-thrombosis of In-stent treated lesions

    Measured: accumulated at 24 months

  14. Procedural success

    final diameter stenosis < 30 % without flow-limiting dissections

    Measured: immediately after procedure

  15. Bleeding complications according to the Bleeding Academic Research Consortium (BARC)

    Measured: accumulated at 3 months

  16. Bleeding complications according to the Bleeding Academic Research Consortium (BARC)

    Measured: accumulated at 12 months

  17. Bleeding complications according to the Bleeding Academic Research Consortium (BARC)

    Measured: accumulated at 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study start30 Apr 2021
  3. Primary completion3 Mar 2026
  4. Study completion31 Mar 2027 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
1,302 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04470934
Sponsor's protocol ID
AAG-O-H-1913
Acronym
SCORE
Status last verified
Jul 2026
First submitted
10 Jul 2020
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Otto S, Diaz VAJ, Weilenmann D, Cuculi F, Nuruddin AA, Leibundgut G, Alfonso F, Wan Ahmad WA, Pyxaras S, Rittger H, Steen P, Gaede L, Schulze C, Wohrle J, Rosenberg M, Waliszewski MW. Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial. BMC Cardiovasc Disord. 2023 Mar 31;23(1):176. doi: 10.1186/s12872-023-03187-x.

    PubMed 37003986

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Myocardial Ischaemia, run by B. Braun Melsungen AG at 1 site in Germany.

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 4 inclusion and 15 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 16 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 1 site in Germany. 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?

Target Lesion Failure (TLF) (time frame: at 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 NCT04470934, which also lists 1 linked publication.

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 16 Jul 2026.

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