- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04796038
Rise Semi Compliant Balloon Study in Patient With CAD
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Geneva, Switzerland, 1205
- HUG
-
-
Valis
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Sion, Valis, Switzerland, 1950
- HVS
-
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Vaud
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Lausanne, Vaud, Switzerland, 1011
- CHUV
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
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).
Exclusion Criteria:
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.
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rise SC
All patients will receive the Rise semi-compliant balloon catheter as per treatment.
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Patient will be treated with balloon dilatation either stand-alone (POBA) or followed by stent implantation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of treated lesions with device success defined as:
Time Frame: During the interventional procedure
|
|
During the interventional procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with Individual components of device success defined as:
Time Frame: During the interventional procedure
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During the interventional procedure
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Percentage of patients with Procedural success defined as:
Time Frame: 1 - 7 Days
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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.
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1 - 7 Days
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Percentage of patients with Target Lesion Failure (TLF)
Time Frame: 1 - 7 Days
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A composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR by CABG or PCI during the index hospitalization.
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1 - 7 Days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marco Roffi, Dr., Hôpitaux Universitaires de Genève (HUG)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-EU-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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