Coronary Artery DiseaseOPreNBiSNCT03518645
Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds
A study testing OPN strategy and standard strategy in people with Coronary Artery Disease and Angina, Unstable, run by KCRI at 1 site in Switzerland.
Trial summary
Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS. Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina, Unstable, Angina, Stable
- What is being tested?
- OPN strategy and standard strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to 29 Mar 2018
- 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
- Age > 18 years.
- Able and willing to give informed consent.
- Willing to comply with specified follow-up evaluations.
- Clinical manifestation of coronary artery disease: stable angina, unstable angina or non-ST-elevation myocardial infarction.
- De novo lesion.
- Angiographic diameter stenosis > 70 % and/or fractional flow reserve <0.80.
Show all 9Show fewer
- Vessel diameter between 2.5 and 4.0 mm.
- One- or two vessel disease (defined as diameter stenosis > 70 % in vessels with a diameter > 2.5 mm).
- Up to two lesions in one or two vessels can be treated.
Who cannot join
- Patient characteristics
- Pregnant or nursing patient or planned pregnancy in the period up to 1 year following the index procedure.
- Patient with contraindication for 12 months of dual antiplatelet therapy.
- ST-elevation myocardial infarction.
- Any contraindication to the implantation of BVS. Lesion characteristics
- Visible thrombus in coronary angiography
- Chronic total occlusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study
Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS.
Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.
Read the detailed description
Study design:
Following pre-dilatation a BVS will be implanted and optical coherence tomography (OCT) will be performed in all patients. After OCT post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. Final OCT will be performed in all patients. 1:1 Randomization of two strategies before the implantation of bioresorbable scaffolds:
- OPN strategy (study group): pre-dilatation with OPN® NC (non-compliant) Super High Pressure PTCA (percutaneous transluminal coronary angioplasty) balloons
- standard strategy (control group): pre-dilatation with a standard (compliant) balloon
Enrolment:
Randomization of 50 patients
- 25 in the OPN strategy (study group)
- 25 in the standard strategy (control group)
- Conditions
- Coronary Artery Disease, Angina, Unstable, Angina, Stable
- Being tested
- OPN strategy, standard strategy
- Keywords
- Coronary Artery Disease, OPN NC, Angina, Stable, Unstable
- Medical subject headings
- Coronary Artery Disease, Angina, Unstable, Angina, Stable, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPN strategyDevice
Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.
standard strategyDevice
Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.
| Study group | Role | What they receive |
|---|---|---|
| OPN strategy | Experimental | The OPN NC Super High Pressure PTCA Balloon will be used as the study device for lesion preparation for BVS Absorb implantation - OPN strategy of lesion preparation. This balloon has a twin layer balloon construction, which allows a very high pressure resistance of 35 bar. The balloon has a 0.016'' lesion entry profile and is available in sizes between 1.5 and 4.5 mm and lengths of 10, 15 and 20 mm. Receives: Device: OPN strategy |
| standard strategy | Active comparator | Predilatation with standard coronary balloon will be performed for lesion preparation for BVS Absorb implantation - standard strategy of lesion preparation. Receives: Device: standard strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons.
Stent apposition will be assessed based on OCT (optical coherence tomography) visualization.
Measured: During the index procedure
Secondary outcomes (8)
Procedural success defined as successful delivery of the scaffold.
The frequency of procedural success will be compared in both study groups.
Measured: During the index procedure
Need for post-dilatation after initial OCT.
The frequency of post-dilatation will be compared in both study groups.
Measured: During the index procedure
Scaffold apposition after post-dilatation.
The scaffold apposition after post-dilatation will be compared based on OCT assessment in both study groups.
Measured: During the index procedure
Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation.
The frequency of periprocedural complications as dissection, slow-flow, no flow and dissection requiring additional stent implantation will be compared separately in both study group.
Measured: During the index procedure
Periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin).
The frequency of periprocedural myocardial infarction will be compared in both study groups.
Measured: During the index procedure
In-stent restenosis requiring revascularization within 12 months post-procedure.
The frequency of in-stent restenosis requiring revascularization will be compared in both study groups in 12 months follow-up.
Measured: 12 months after the index procedure
Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure.
The frequency of stent thrombosis will be compared in both study groups in 12 months follow-up.
Measured: 12 months after the index procedure
Death or myocardial infarction within 12 months post procedure.
The frequency of death and myocardial infarction will be compared separately in both study groups in 12 months follow-up.
Measured: 12 months after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study startMar 2015
- Primary completionDec 2016
- Study completion29 Mar 2018
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
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCRI
- Sponsor type
- University, hospital or other
- Collaborators
- SIS Medical AG
- Responsible party
- Principal investigator, Wojciech Zasada, KCRI
- Investigators
- Florim Cuculi, MD, PhD, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518645
- Sponsor's protocol ID
- OPreNBiS
- Acronym
- OPreNBiS
- Status last verified
- May 2018
- First submitted
- 20 Apr 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ayton SL, Aslam S, Dattani A, Yeo JL, Gulsin GS, Slomka PJ, Dey D, McCann GP, Singh A. Association of epicardial adipose tissue with markers of cardiac remodelling and clinical outcomes in asymptomatic aortic stenosis. Open Heart. 2026 Feb 9;13(1):e003804. doi: 10.1136/openhrt-2025-003804.
PubMed 41663151Cuculi F, Bossard M, Zasada W, Moccetti F, Voskuil M, Wolfrum M, Malinowski KP, Toggweiler S, Kobza R. Performing percutaneous coronary interventions with predilatation using non-compliant balloons at high-pressure versus conventional semi-compliant balloons: insights from two randomised studies using optical coherence tomography. Open Heart. 2020 Jan 23;7(1):e001204. doi: 10.1136/openhrt-2019-001204. eCollection 2020.
PubMed 32076567
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study
- ClinicalTrials.gov ID
- NCT03518645
- Acronym / sponsor ID
- OPreNBiS / OPreNBiS
- Conditions
- Coronary Artery Disease, Angina, Unstable, Angina, Stable
- Keywords
- Coronary Artery Disease, OPN NC, Angina, Stable, Unstable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- KCRIUniversity, hospital or other
- Collaborators
- SIS Medical AG
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 8 May 2018 (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.
Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS.
Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.
Detailed description
Study design:
Following pre-dilatation a BVS will be implanted and optical coherence tomography (OCT) will be performed in all patients. After OCT post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. Final OCT will be performed in all patients. 1:1 Randomization of two strategies before the implantation of bioresorbable scaffolds:
- OPN strategy (study group): pre-dilatation with OPN® NC (non-compliant) Super High Pressure PTCA (percutaneous transluminal coronary angioplasty) balloons
- standard strategy (control group): pre-dilatation with a standard (compliant) balloon
Enrolment:
Randomization of 50 patients
- 25 in the OPN strategy (study group)
- 25 in the standard strategy (control group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPN strategy | Experimental | Device: OPN strategyThe OPN NC Super High Pressure PTCA Balloon will be used as the study device for lesion preparation for BVS Absorb implantation - OPN strategy of lesion preparation. This balloon has a twin layer balloon construction, which allows a very high pressure resistance of 35 bar. The balloon has a 0.016'' lesion entry profile and is available in sizes between 1.5 and 4.5 mm and lengths of 10, 15 and 20 mm. |
| standard strategy | Active comparator | Device: standard strategyPredilatation with standard coronary balloon will be performed for lesion preparation for BVS Absorb implantation - standard strategy of lesion preparation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years.
- Able and willing to give informed consent.
- Willing to comply with specified follow-up evaluations.
- Clinical manifestation of coronary artery disease: stable angina, unstable angina or non-ST-elevation myocardial infarction.
- De novo lesion.
Key exclusion criteria (7 listed)
- Patient characteristics
- Pregnant or nursing patient or planned pregnancy in the period up to 1 year following the index procedure.
- Patient with contraindication for 12 months of dual antiplatelet therapy.
- ST-elevation myocardial infarction.
- Any contraindication to the implantation of BVS. Lesion characteristics
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 |
|---|---|---|
| OPN strategyPredilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation. | Device | OPN strategy |
| standard strategyPredilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation. | Device | standard strategy |
Primary outcome
Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons.
Time frame: During the index procedure
Stent apposition will be assessed based on OCT (optical coherence tomography) visualization.
8 secondary outcomes
Procedural success defined as successful delivery of the scaffold.
Time frame: During the index procedure
Need for post-dilatation after initial OCT.
Time frame: During the index procedure
Scaffold apposition after post-dilatation.
Time frame: During the index procedure
Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation.
Time frame: During the index procedure
Periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin).
Time frame: During the index procedure
In-stent restenosis requiring revascularization within 12 months post-procedure.
Time frame: 12 months after the index procedure
Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure.
Time frame: 12 months after the index procedure
Death or myocardial infarction within 12 months post procedure.
Time frame: 12 months after the index procedure
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 8 May 2018.
- Derived from this study: PubMed 41663151Ayton SL, Aslam S, Dattani A, Yeo JL, Gulsin GS, Slomka PJ, Dey D, McCann GP, Singh A. Association of epicardial adipose tissue with markers of cardiac remodelling and clinical outcomes in asymptomatic aortic stenosis. Open Heart. 2026 Feb 9;13(1):e003804. doi: 10.1136/openhrt-2025-003804.
- Derived from this study: PubMed 32076567Cuculi F, Bossard M, Zasada W, Moccetti F, Voskuil M, Wolfrum M, Malinowski KP, Toggweiler S, Kobza R. Performing percutaneous coronary interventions with predilatation using non-compliant balloons at high-pressure versus conventional semi-compliant balloons: insights from two randomised studies using optical coherence tomography. Open Heart. 2020 Jan 23;7(1):e001204. doi: 10.1136/openhrt-2019-001204. eCollection 2020.
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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.
Florim Cuculi, MD, PhD principal investigator
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPN strategy and standard strategy in people with Coronary Artery Disease and Angina, Unstable, run by KCRI at 1 site in Switzerland.
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 9 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 8 May 2018. 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 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?
Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons. (time frame: During the index procedure). 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 NCT03518645, 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 8 May 2018.