Coronary Artery DiseaseSCBDENOVONCT03908450
Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter
A study testing PTCA of coronary de novo lesion PCB and PTCA of coronary de novo lesion SCB in people with Coronary Artery Disease, run by InnoRa GmbH at 4 sites in 2 countries.
Trial summary
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PTCA of coronary de novo lesion PCB and PTCA of coronary de novo lesion SCB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 25 Sep 2019to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Clinical evidence of stable or unstable angina or a positive functional study
- Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to <70% diameter stenosis with positive functional test or symptom of ischemia)
- Successful lesion preparation (no flow-limiting dissection or a residual stenosis > 30%)
Who cannot join
- Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)
- Intolerance and / or allergy to Sirolimus
- Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:
- iopromide)
- Patients with an ejection fraction of < 30 %
- Reference vessel diameter (RVD) < 2.5 mm
- Contraindication for whichever necessary accompanying medication
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
Dresden, 01307
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Homburg/Saar, Saarland, 66421
Klinik für Innere Medizin III - Kardiologie Paul Gerhardt Stift
Wittenberg, 06886
About this study
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon
Read the detailed description
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical follow up
Key inclusion criteria: > 18 years of age, Clinical evidence of stable or unstable angina or a positive functional study, Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to <70% diameter stenosis with positive functional test or symptom of ischemia), Successful lesion preparation (no flow-limiting dissection or a residual stenosis > 30%).
Key exclusion criteria: Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI), Intolerance and / or allergy to Sirolimus, Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: iopromide), Patients with an ejection fraction of < 30 %, Reference vessel diameter (RVD) < 2.5 mm, Contraindication for whichever necessary accompanying medication.
Primary efficacy endpoint: late lumen loss in-segment at 6 months. Key secondary endpoints: Procedural Success: < 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE. MACE: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization in-hospital at 6 and at 12 months Individual clinical endpoints at 6 and at 12 months: cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, (stenosis ≥ 50% at follow-up angiography)
- Conditions
- Coronary Artery Disease
- Being tested
- PTCA of coronary de novo lesion PCB, PTCA of coronary de novo lesion SCB
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTCA of coronary de novo lesion PCBDevice
PTCA of coronary de novo lesion with drug coated balloon
PTCA of coronary de novo lesion SCBDevice
PTCA of coronary de novo lesion with drug coated balloon
| Study group | Role | What they receive |
|---|---|---|
| Control intervention | Active comparator | Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²) Receives: Device: PTCA of coronary de novo lesion PCB |
| Experimental intervention | Experimental | Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²) Receives: Device: PTCA of coronary de novo lesion SCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
late lumen loss in-segment
angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline
Measured: 6 months
Secondary outcomes (2)
Procedural Success
< 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE
Measured: in hospital
MACE MACE
cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months
Measured: at 6 and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start25 Sep 2019
- Primary completion30 Apr 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnoRa GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruno Scheller, MD, Principal investigator, Clinical and Experimental Interventional Cardiology, University of Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908450
- Sponsor's protocol ID
- SI-DN-01
- Acronym
- SCBDENOVO
- Status last verified
- Feb 2024
- First submitted
- 2 Apr 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.
PubMed 30898253Scheller B, Mangner N, Jeger RV, Afan S, Mahfoud F, Woitek FJ, Fahrni G, Schwenke C, Schnorr B, Kleber F. A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions. EuroIntervention. 2024 Nov 4;20(21):e1322-e1329. doi: 10.4244/EIJ-D-23-00868.
PubMed 39492703
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter
- ClinicalTrials.gov ID
- NCT03908450
- Acronym / sponsor ID
- SCBDENOVO / SI-DN-01
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- InnoRa GmbHIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 9 Apr 2019 (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.
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon
Detailed description
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical follow up
Key inclusion criteria: > 18 years of age, Clinical evidence of stable or unstable angina or a positive functional study, Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to <70% diameter stenosis with positive functional test or symptom of ischemia), Successful lesion preparation (no flow-limiting dissection or a residual stenosis > 30%).
Key exclusion criteria: Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI), Intolerance and / or allergy to Sirolimus, Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: iopromide), Patients with an ejection fraction of < 30 %, Reference vessel diameter (RVD) < 2.5 mm, Contraindication for whichever necessary accompanying medication.
Primary efficacy endpoint: late lumen loss in-segment at 6 months. Key secondary endpoints: Procedural Success: < 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE. MACE: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization in-hospital at 6 and at 12 months Individual clinical endpoints at 6 and at 12 months: cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, (stenosis ≥ 50% at follow-up angiography)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Control intervention | Active comparator | Device: PTCA of coronary de novo lesion PCBPredilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²) |
| Experimental intervention | Experimental | Device: PTCA of coronary de novo lesion SCBPredilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical evidence of stable or unstable angina or a positive functional study
- Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to <70% diameter stenosis with positive functional test or symptom of ischemia)
- Successful lesion preparation (no flow-limiting dissection or a residual stenosis > 30%)
Key exclusion criteria (7 listed)
- Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)
- Intolerance and / or allergy to Sirolimus
- Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:
- iopromide)
- Patients with an ejection fraction of < 30 %
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 |
|---|---|---|
| PTCA of coronary de novo lesion PCBPTCA of coronary de novo lesion with drug coated balloon | Device | Control intervention |
| PTCA of coronary de novo lesion SCBPTCA of coronary de novo lesion with drug coated balloon | Device | Experimental intervention |
Primary outcome
late lumen loss in-segment
Time frame: 6 months
angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline
2 secondary outcomes
Procedural Success
Time frame: in hospital
MACE MACE
Time frame: at 6 and at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 30898253Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.
- Derived from this study: PubMed 39492703Scheller B, Mangner N, Jeger RV, Afan S, Mahfoud F, Woitek FJ, Fahrni G, Schwenke C, Schnorr B, Kleber F. A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions. EuroIntervention. 2024 Nov 4;20(21):e1322-e1329. doi: 10.4244/EIJ-D-23-00868.
- Individual participant dataSharing planned: No
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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.
Bruno Scheller, MD principal investigator
Clinical and Experimental Interventional Cardiology, University of Saarland
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTCA of coronary de novo lesion PCB and PTCA of coronary de novo lesion SCB in people with Coronary Artery Disease, run by InnoRa GmbH at 4 sites in 2 countries.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
late lumen loss in-segment (time frame: 6 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 NCT03908450, which also lists 2 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 Feb 2024.