An interventional study of PCI and PCI in Coronary Artery Disease (CAD), sponsored by B. Braun Melsungen AG. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by B. Braun Melsungen AG · Not applicable, Interventional, and Treatment
The main objective of this randomized, multicenter, international, open-label clinical trial is to demonstrate that, in the context of percutaneous coronary intervention for complex coronary artery disease, a SeQuent® SCB interventional strategy is non-inferior to a new-generation
DES strategy in terms of a 12- and 36-month composite of Target Vessel Failure (TVF), that includes:
Eligible subjects will be assigned in a 1:1 ratio to receive treatment of all lesions with either the SeQuent® SCB-based strategy or a DES-based strategy. The randomization will be performed prior to the index procedure once signed informed consent has been obtained and all eligibility criteria have been confirmed.
All Subjects will be followed for clinical outcomes at 3 months, 1, 2, and 3 years. A subset of 138 randomized patients will undergo control angiography after one-year clinical follow-up (+1 month). An independent core laboratory will analyze all baseline angiograms.
If, at 36 months, the non-inferiority of the SeQuent® SCB strategy compared to the DES strategy is achieved, superiority in terms of TVF and BARC Type 3-5 bleeding will be tested.
An optional extension of follow-up to 6 years may be implemented based on interim results and the joint decision of the Steering Committee and the Sponsor. Details regarding this optional extension are provided in the Clinical Investigation Plan.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 2,184 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →B. Braun Melsungen AG is the lead sponsor of 47 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject must have at least one of the high clinical or anatomical risk features:
High clinical risk, defined as:
OR
High anatomical risk lesions requiring treatment as follows:
In the case of multivessel (MV) disease, multiple vessels can be treated provided that all lesions are amenable to treatment with either DCB or DES and vessel size at the site of the lesion is >2.0 mm by visual assessment.
The trial does not restrict the number of target lesions. However, the operator should determine that all target lesions intended to be treated must be suitable for treatment with either DES or DCB. For patients randomized to the DCB arm, the likelihood of requiring provisional stenting must be assessed as less than 30% for each lesion requiring treatment.
Exclusion Criteria:
Angiographic exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
all target lesions should be treated with the SeQuent® SCB after adequate lesion preparation. If the angiographic result is unacceptable following lesion preparation or after DCB treatment (e.g., flow-limiting dissection or residual stenosis \>30%), additional therapeutic steps should be considered. For non-left main bifurcation lesions, if the side branch requires treatment, it should also be treated with the SeQuent® SCB after adequate lesion preparation. If an unacceptable angiographic result, defined as \>70% residual stenosis or major recoil at the side branch ostium, is obtained, or if there is an imminent risk of vessel compromise, further therapeutic steps are required. Those steps may include optimized lesion preparation to avoid DES implantation; however, DES may be implanted if all other attempts fail.
Device: PCI
all target lesions should be treated with DES. The use of DCB in the DES arm is strongly discouraged. If DES delivery is not feasible due to anatomical or other reasons, the operator may consider alternative treatments, such as more deliverable DES or plain old balloon angioplasty (POBA), while keeping the patients in the DES group. In case of bifurcation treatment, both DES and POBA are allowed. Any use of DCB in the DES arm shall be justified.
Device: PCI
PCI with SeQuent® SCB
PCI with DES
Composite of Target Vessel Failure (TVF) and bleeding according to Bleeding Academic Research Consortium (BARC) Types 3-5
Time frame: at 12 months (after intervention)
Composite of TVF and bleeding BARC 3-5
Time frame: at 36 months
Composite of TVF and bleeding BARC 3-5
Time frame: at 3 months
Composite of TVF and bleeding BARC 3-5
Time frame: at 24 months
Device-oriented Composite Endpoint (DOCE)
a composite of cardiovascular death (CV death), device failure-related myocardial infarction (MI), and clinically indicated Target Lesion Revascularization (ci-TLR)
Time frame: at 3 months
DOCE
Time frame: at 12 months
DOCE
Time frame: at 24 months
DOCE
Time frame: at 36 months
TVF
Time frame: at 3 months
TVF
Time frame: at 12 months
TVF
Time frame: at 24 months
TVF
Time frame: at 36 months
Patient-oriented Composite endpoint (POCE)
a composite of any death, any MI, any stroke, and any revascularization
Time frame: at 3 months
POCE
Time frame: at 12 months
POCE
Time frame: at 24 months
POCE
Time frame: at 36 months
Any death
Time frame: at 3 months
Any death
Time frame: at 12 months
Any death
Time frame: at 24 months
Any death
Time frame: at 36 months
CV death
Time frame: at 3 months
CV death
Time frame: at 12 months
CV death
Time frame: at 24 months
CV death
Time frame: at 36 months
Cardiac death
Time frame: at 3 months
Cardiac death
Time frame: at 12 months
Cardiac death
Time frame: at 24 months
Cardiac death
Time frame: at 36 months
Any MI
Time frame: at 3 months
Any MI
Time frame: at 12 months
Any MI
Time frame: at 24 months
Any MI
Time frame: at 36 months
Target Vessel-Related MI
Time frame: at 3 months
Target Vessel-Related MI
Time frame: at 12 months
Target Vessel-Related MI
Time frame: at 24 months
Target Vessel-Related MI
Time frame: at 36 months
Peri-procedural MI
as defined by Drug Coated Balloon Academic Research Consortium (DCB ARC)
Time frame: at 3 months
Peri-procedural MI
Time frame: at 12 months
Peri-procedural MI
Time frame: at 24 months
Peri-procedural MI
Time frame: at 36 months
Spontaneous MI
according to 4th Universal Definition of MI
Time frame: at 3 months
Spontaneous MI
Time frame: at 12 months
Spontaneous MI
Time frame: 24 months
Spontaneous MI
Time frame: at 36 months
BARC type ≥2 bleeding
Time frame: at 3 months
BARC type ≥2 bleeding
Time frame: at 12 months
BARC type ≥2 bleeding
Time frame: at 24 months
BARC type ≥2 bleeding
Time frame: at 36 months
BARC 3-5 bleeding
Time frame: at 3 months
BARC 3-5 bleeding
Time frame: at 12 months
BARC 3-5 bleeding
Time frame: at 24 months
BARC 3-5 bleeding
Time frame: at 36 months
Definite stent/lesion thrombosis
Time frame: at 3 months
Definite stent/lesion thrombosis
Time frame: at 12 months
Definite stent/lesion thrombosis
Time frame: at 24 months
Definite stent/lesion thrombosis
Time frame: at 36 months
Stroke
ischemic and hemorrhagic
Time frame: at 3 months
Stroke
Time frame: at 12 months
Stroke
Time frame: at 24 months
Stroke
Time frame: at 36 months
Any TLR
Time frame: at 3 months
Any TLR
Time frame: at 12 months
Any TLR
Time frame: at 24 months
Any TLR
Time frame: at 36 months
ci-TLR
Time frame: at 3 months
ci-TLR
Time frame: at 12 months
ci-TLR
Time frame: at 24 months
ci-TLR
Time frame: at 36 months
Any TVR
Time frame: at 3 months
Any TVR
Time frame: at 12 months
Any TVR
Time frame: at 24 months
Any TVR
Time frame: at 36 months
ci-TVR
Time frame: at 3 months
ci-TVR
Time frame: at 12 months
ci-TVR
Time frame: at 24 months
ci-TVR
Time frame: at 36 months
Dual Antiplatelet Therapy (DAPT) burden
total duration of DAPT and/or Single Antiplatelet Therapy (SAPT)
Time frame: at 3 months
DAPT burden
Time frame: at 12 months
DAPT burden
Time frame: at 24 months
DAPT burden
Time frame: at 36 months
Hospitalization related to study endpoints
Time frame: at 3 months
Hospitalization related to study endpoints
Time frame: at 12 months
Hospitalization related to study endpoints
Time frame: at 24 months
Hospitalization related to study endpoints
Time frame: at 36 months
Procedure success
defined as Device success and freedom from in-hospital cardiovascular death, TLR, peri-procedural MI, any stroke, and BARC 3 or 5 bleeding
Time frame: at 3 months
Procedure success
Time frame: at 12 months
Procedure success
Time frame: at 24 months
Procedure success
Time frame: at 36 months
Device success (DCB)
defined as successful delivery in time and inflation within 30-60 s of the allocated DCB device at the intended target lesion during an attempt with a DCB not previously used (first use); successful withdrawal of the device system; attainment of a final in-segment or in-lesion residual stenosis of \<30% (except in the side branch ostium in nonleft main bifurcation lesions \<70%) by visual estimate
Time frame: at 3 months
Device success (DCB)
Time frame: at 12 months
Device success (DCB)
Time frame: at 24 months
Device success (DCB)
Time frame: at 36 months
Device success (DES)
defined as successful delivery, balloon expansion, and deployment of the first assigned DES at the intended target lesion; successful withdrawal of the device delivery system; attainment of a final in-stent residual stenosis of \<20% by visual estimate
Time frame: at 3 months
Device success (DES)
Time frame: at 12 months
Device success (DES)
Time frame: at 24 months
Device success (DES)
Time frame: at 36 months
Metal burden
by assessing the total stent length
Time frame: at 3 months
Metal burden
Time frame: at 12 months
Metal burden
Time frame: at 24 months
Metal burden
Time frame: at 36 months
In-segment net gain
Main angiographic endpoint after completion of the 12-month follow-up
Time frame: assessed between 12 and 13 months
Cost-effectiveness of DCB-based vs. DES-based strategy
Time frame: at 12 months
Cost-effectiveness of DCB-based vs. DES-based strategy
Time frame: at 24 months
Cost-effectiveness of DCB-based vs. DES-based strategy
Time frame: at 36 months
Plan to share: No
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