Rise Semi Compliant Balloon Study in Patient With CAD

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796038
• Other study ID #: 20-EU-02
• Status: Completed
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: November 9, 2022

Study information

• Verified date: June 2022
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 9, 2022
• Est. primary completion date: November 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• General Inclusion Criteria

1. Subject must be at least 18 years of age.

2. Subject or a legally authorised representative must provide written informed consent prior to any study related procedure.

3. Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.

4. Subject must agree to undergo all protocol-required follow-up procedures.

5. 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.

1. De novo or restenotic lesions in native coronary arteries or bypass grafts.

2. A maximum of two lesions, with either both in one vessel or one lesion in each of two vessels.

3. 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

1. Planned use of a non-study angioplasty balloon during the procedure for pre-dilatation or dilatation of the lesion.

2. 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.

3. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.

4. Subject is currently participating in an investigational study that may confound the treatment or outcomes of this study.

5. 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.

1. Unprotected left main coronary artery disease

2. 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.

3. Coronary artery spasm in the absence of significant stenosis.

4. 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.

5. 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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Balloon dilatation
Patient will be treated with balloon dilatation either stand-alone (POBA) or followed by stent implantation.

Locations

Country	Name	City	State
Switzerland	HUG	Geneva
Switzerland	CHUV	Lausanne	Vaud
Switzerland	HVS	Sion	Valis

Sponsors (1)

Lead Sponsor	Collaborator
Biosensors Europe SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))	During the interventional procedure
Secondary	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)	During the interventional procedure
Secondary	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.	1 - 7 Days
Secondary	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.	1 - 7 Days