Coronary Artery DiseaseNCT04796038
Rise Semi Compliant Balloon Study in Patient With CAD
A study testing Balloon dilatation in people with Coronary Artery Disease, run by Biosensors Europe SA at 3 sites in Switzerland.
Trial summary
Single arm, prospective, multi-center, trial designed to enrol approximately 66 patients. All patients will undergo PCI using at least one RISE SC balloon as per routine clinical practice and will be followed until discharge for data collection. 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?
- Balloon dilatation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 31 Jan 2022to 9 Nov 2022
- 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
- General Inclusion Criteria
- Subject must be at least 18 years of age.
- Subject or a legally authorised representative must provide written informed consent prior to any study related procedure.
- Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.
- Subject must agree to undergo all protocol-required follow-up procedures.
- Subject must agree not to participate in any other clinical study during hospitalisation for the index procedure.
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- Angiographic Inclusion Criteria All angiographic inclusion criteria are based on visual estimation.
- De novo or restenotic lesions in native coronary arteries or bypass grafts.
- A maximum of two lesions, with either both in one vessel or one lesion in each of two vessels.
- The target lesion(s) must have a diameter stenosis of ≥ 50% by visual estimation or online quantitative coronary angiography (QCA) and may include chronic total occlusions (CTO).
Who cannot join
- General Exclusion Criteria
- Planned use of a non-study angioplasty balloon during the procedure for pre-dilatation or dilatation of the lesion.
- Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, other anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-treated.
- Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
- Subject is currently participating in an investigational study that may confound the treatment or outcomes of this study.
- Subject is pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
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- Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.
- Unprotected left main coronary artery disease
- More than two lesions requiring treatment. Tandem lesions, defined as multiple, focal lesions that can be covered by one balloon, will be considered as a single lesion.
- Coronary artery spasm in the absence of significant stenosis.
- Anticipated need for plaque modification using rotational/orbital atherectomy or intravascular lithotripsy. Note: The use of scoring or cutting balloons after (pre)-dilatation with the study device is allowed.
- Additional clinically significant lesion(s) in any coronary arteries or bypass grafts for which PCI may be required during hospitalization for the index procedure (in-hospital staged PCI).
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
HUG
Geneva, 1205
CHUV
Lausanne, Canton of Vaud, 1011
HVS
Sion, Valis, 1950
About this study
Official title: Evaluation of the Acute Safety and Device Success of the RISE SC Coronary Balloon Dilatation Catheter When Used as a Dilatation Device in the Stenotic Portion of a Coronary Artery or Bypass Graft in Patients With Coronary Artery Disease
Single arm, prospective, multi-center, trial designed to enrol approximately 66 patients. All patients will undergo PCI using at least one RISE SC balloon as per routine clinical practice and will be followed until discharge for data collection. Patients will be enrolled in up to 5 investigational sites in Switzerland.
The patients will be followed up until discharge or until 7 days, whichever comes first.
- Conditions
- Coronary Artery Disease
- Being tested
- Balloon dilatation
- 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.
Balloon dilatationDevice
Patient will be treated with balloon dilatation either stand-alone (POBA) or followed by stent implantation.
| Study group | Role | What they receive |
|---|---|---|
| Rise SC | Experimental | All patients will receive the Rise semi-compliant balloon catheter as per treatment. Receives: Device: Balloon dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of treated lesions with device success defined as:
- Successful device delivery and
- Successful inflation and deflation of the balloon and
- No perforation, flow-limiting dissection or reduction in TIMI flow grade and
- No life-threatening arrhythmias (sustained Ventricular Tachycardia (VT), Ventricular Fibrillation (VF))
Measured: During the interventional procedure
Secondary outcomes (3)
Percentage of patients with Individual components of device success defined as:
- Successful device delivery
- Successful inflation and deflation of the balloon
- No perforation, flow-limiting dissection or reduction in TIMI flow grade
- No life-threatening arrhythmias (sustained VT, VF)
Measured: During the interventional procedure
Percentage of patients with Procedural success defined as:
Device success without major adverse cardiovascular events (MACE) which is a composite of all death, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR) by coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) during the index hospitalization.
Measured: 1 - 7 Days
Percentage of patients with Target Lesion Failure (TLF)
A composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR by CABG or PCI during the index hospitalization.
Measured: 1 - 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start31 Jan 2022
- Primary completion9 Nov 2022
- Study completion9 Nov 2022
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Roffi, Dr., Principal investigator, Hôpitaux universitaires de Genève (HUG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796038
- Sponsor's protocol ID
- 20-EU-02
- Status last verified
- Jun 2022
- First submitted
- 10 Feb 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The emphasis in all scientific publications and presentations will be placed on the endpoint at discharge.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acute Safety and Device Success of the RISE SC Coronary Balloon Dilatation Catheter When Used as a Dilatation Device in the Stenotic Portion of a Coronary Artery or Bypass Graft in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04796038
- Acronym / sponsor ID
- 20-EU-02
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 12 Mar 2021 (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.
Single arm, prospective, multi-center, trial designed to enrol approximately 66 patients. All patients will undergo PCI using at least one RISE SC balloon as per routine clinical practice and will be followed until discharge for data collection. Patients will be enrolled in up to 5 investigational sites in Switzerland.
The patients will be followed up until discharge or until 7 days, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rise SC | Experimental | Device: Balloon dilatationAll patients will receive the Rise semi-compliant balloon catheter as per treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- General Inclusion Criteria
- Angiographic Inclusion Criteria All angiographic inclusion criteria are based on visual estimation.
Key exclusion criteria (12 listed)
- General Exclusion Criteria
- Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.
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 |
|---|---|---|
| Balloon dilatationPatient will be treated with balloon dilatation either stand-alone (POBA) or followed by stent implantation. | Device | Rise SC |
Primary outcome
Percentage of treated lesions with device success defined as:
Time frame: During the interventional procedure
1. Successful device delivery and 2. Successful inflation and deflation of the balloon and 3. No perforation, flow-limiting dissection or reduction in TIMI flow grade and 4. No life-threatening arrhythmias (sustained Ventricular Tachycardia (VT), Ventricular Fibrillation (VF))
3 secondary outcomes
Percentage of patients with Individual components of device success defined as:
Time frame: During the interventional procedure
Percentage of patients with Procedural success defined as:
Time frame: 1 - 7 Days
Percentage of patients with Target Lesion Failure (TLF)
Time frame: 1 - 7 Days
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 25 Jan 2023.
- Individual participant dataSharing planned: Yes. The emphasis in all scientific publications and presentations will be placed on the endpoint at discharge.
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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.
Marco Roffi, Dr. principal investigator
Hôpitaux universitaires de Genève (HUG)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon dilatation in people with Coronary Artery Disease, run by Biosensors Europe SA at 3 sites 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 10 inclusion and 12 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 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Percentage of treated lesions with device success defined as: (time frame: During the interventional procedure). 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 25 Jan 2023.