Coronary Artery DiseaseNCT02468960
Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)
A study testing Predilatation with OPN NC balloon catheter., Predilatation with standard compliant balloon. and Absorb BVS implantation. in people with Coronary Artery Disease and Angina, run by SIS Medical AG at 1 site in Switzerland.
Trial summary
Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS (Bioresorbable Vascular Scaffold). Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. 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
- What is being tested?
- Predilatation with OPN NC balloon catheter., Predilatation with standard compliant balloon. and Absorb BVS implantation.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to Dec 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.
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- 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 (Bioresorbable Vascular Scaffold).
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 ® 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 Angina
- Being tested
- Predilatation with OPN NC balloon catheter., Predilatation with standard compliant balloon., Absorb BVS implantation., Treated segment visualization by OCT., Clinical FU at 12 months.
- Keywords
- Coronary Artery Disease, OPN NC, Angina, Stable, Unstable
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Angina, Unstable, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predilatation with OPN NC balloon catheter.Device
Target lesion will be prepared by predilatation with OPN NC balloon catheter.
Predilatation with standard compliant balloon.Device
Target lesion will be prepared by predilatation with standard balloon catheter (compliant).
Absorb BVS implantation.Device
After lesion preparation implantation of BVS Absorb scaffold will be performed.
Treated segment visualization by OCT.Procedure or surgery
Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).
Clinical FU at 12 months.Other
All patients will be clinically followed for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| OPN strategy (study group) | Other | Interventions planned in this arm are as follows:
* Predilatation with OPN NC balloon catheter.
* Absorb BVS implantation.
* Treated segment visualization by OCT.
* Clinical FU at 12 months. Receives: Device: Predilatation with OPN NC balloon catheter.; Device: Absorb BVS implantation.; Procedure: Treated segment visualization by OCT.; Other: Clinical FU at 12 months. |
| Standard strategy (control group) | Other | Interventions planned in this arm are as follows:
* Predilatation with standard compliant balloon.
* Absorb BVS implantation.
* Treated segment visualization by OCT.
* Clinical FU at 12 months. Receives: Device: Predilatation with standard compliant balloon.; Device: Absorb BVS implantation.; Procedure: Treated segment visualization by OCT.; Other: Clinical FU at 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section
Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Secondary outcomes (4)
Procedural success defined as successful delivery of the scaffold
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Need for post-dilatation after implantation of the scaffold
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Scaffold apposition after post-dilatation
Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Frequency and total number of periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation,
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIS Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florim Cuculi, Prof. dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468960
- Sponsor's protocol ID
- OPreNBiS
- Status last verified
- Apr 2017
- First submitted
- 4 Mar 2015
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. 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
- NCT02468960
- Acronym / sponsor ID
- OPreNBiS
- Conditions
- Coronary Artery Disease, Angina, Unstable Angina, Stable Angina
- Keywords
- Coronary Artery Disease, OPN NC, Angina, Stable, Unstable
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- SIS Medical AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 Jun 2015 (estimated)
- 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 (Bioresorbable Vascular Scaffold).
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 ® 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 (study group) | Other | Device: Predilatation with OPN NC balloon catheter., Device: Absorb BVS implantation., Procedure: Treated segment visualization by OCT., Other: Clinical FU at 12 months.Interventions planned in this arm are as follows: * Predilatation with OPN NC balloon catheter. * Absorb BVS implantation. * Treated segment visualization by OCT. * Clinical FU at 12 months. |
| Standard strategy (control group) | Other | Device: Predilatation with standard compliant balloon., Device: Absorb BVS implantation., Procedure: Treated segment visualization by OCT., Other: Clinical FU at 12 months.Interventions planned in this arm are as follows: * Predilatation with standard compliant balloon. * Absorb BVS implantation. * Treated segment visualization by OCT. * Clinical FU at 12 months. |
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
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 |
|---|---|---|
| Predilatation with OPN NC balloon catheter.Target lesion will be prepared by predilatation with OPN NC balloon catheter. | Device | OPN strategy (study group) |
| Predilatation with standard compliant balloon.Target lesion will be prepared by predilatation with standard balloon catheter (compliant). | Device | Standard strategy (control group) |
| Absorb BVS implantation.After lesion preparation implantation of BVS Absorb scaffold will be performed. | Device | OPN strategy (study group), Standard strategy (control group) |
| Treated segment visualization by OCT.Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT). | Procedure or surgery | OPN strategy (study group), Standard strategy (control group) |
| Clinical FU at 12 months.All patients will be clinically followed for 12 months. | Other | OPN strategy (study group), Standard strategy (control group) |
Primary outcome
Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.
4 secondary outcomes
Procedural success defined as successful delivery of the scaffold
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Need for post-dilatation after implantation of the scaffold
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Scaffold apposition after post-dilatation
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Frequency and total number of periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation,
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
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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, Prof. dr principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predilatation with OPN NC balloon catheter., Predilatation with standard compliant balloon. and Absorb BVS implantation. in people with Coronary Artery Disease and Angina, run by SIS Medical AG 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: status not confirmed, as of the sponsor's last update on 31 Oct 2017. 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?
Results are not available in the source record.
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?
Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section (time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2017.