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ADVANCEd NanoTherapies Dual Active Pharmacological Ingredient (Dual-API) Drug-Coated Balloon to Treat De-Novo Lesions in Patients With Symptomatic Stable Coronary Artery Disease (ADVANCE-DCB)

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
SirPlux™ Duo Dual-API Coated PTCA Balloon Catheter
Sponsored by
Advanced NanoTherapies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug Coated Ballon, DCB, Coronary Artery Disease

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The subject is ≥18 years and <90 years old. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. Life expectancy > 1 year. The subject is intended to undergo an angiographic procedure and coronary percutaneous intervention. The subject is an acceptable candidate for treatment in the Investigator's opinion and/or per hospital guidelines. The subject is intended to undergo treatment with a coronary drug-coated balloon. Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure. Men with a female partner of childbearing potential must agree to use condoms plus an additional reliable contraceptive method within 12 months after the index procedure. The subject is able and willing to comply with all assessments in the study, including dual antiplatelet therapy (DAPT), ASA indefinitely, and P2Y12 inhibitor for a minimum of 6 months. The subject shall be under optimal medical therapy for ASCVD, which includes at a minimum high-intensity statin therapy (atorvastatin 40-80 mg/d or rosuvastatin 20-40 mg/d). If statin intolerant, the patient should be treated with a PCSK9 inhibitor, ezetimibe or bempedoic acid. Subject has chronic stable angina or has had an acute coronary syndrome and the cardiac biomarkers have returned to normal Target lesion is located within a de-novo coronary artery located in a native coronary artery with a reference vessel diameter between ≥2.25 mm to ≤4.0mm by visual estimate, with a lesion length of equal greater 15mm to < 35mm. Subject has multiple lesions that meet inclusion and exclusion criteria individually that could be treated with a study device. To be treated with a study device, lesions must be defined as target lesions. A maximum of three (3) lesions could be treated during the index procedure (maximum of 2 target vessels). One (1) non-target lesion can be staged if needed. Target lesions (up tp 2) cannot be staged. One investigational device is to be used per target lesion. Successful pre-dilation with semi and/or non-compliant balloon of the target lesion(s) is defined as no major flow-limiting dissections (Grade C or higher) and ≤30% residual stenosis of the target lesion by a visual estimate on angiography. Adjunctive therapy pre-dilation therapies such as scoring balloon, cutting balloon, and IVL are allowed. Rotablator or similar rotational atherectomy devices are restricted per protocol. Exclusion Criteria: General Exclusion Criteria: Subject has other serious medical illnesses (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months. Subject has current problems with substance abuse. Subject has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. Subject participates in another investigational drug or device clinical study that has not reached its primary endpoint. Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure. Significant target vessel tortuosity or other parameters that could prohibit access to the target lesion. Type A lesions, Chronic total occlusion (CTO) of the target lesion(s) or Thrombolysis In Myocardial Infarction (TIMI) flow < 2. Cardiogenic shock. Subject requires treatment of a coronary lesion(s) involving a bifurcation. Target lesion(s) within native or synthetic vessel grafts. CTO of inflow vessel. Subject has had any major (e.g., cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days before the index procedure or has a planned major surgical procedure or intervention within 30 days of the index procedure. Subject requires treatment of a coronary lesion distal to the target lesion(s) at the time of the enrollment/index procedure. The subject has a known coagulopathy or has a bleeding diathesis, thrombocytopenia (with platelet counts less than 100,000/microliter) or platelets > 400,000/microliter, or international normalized ratio >1.5. Patients on chronic oral anticoagulation medications will be excluded of the study Known renal insufficiency (e.g., serum creatinine >2.5mg/dL, or creatinine clearance (CrCl) ≤30 mL/min). Subject on dialysis, or acute kidney failure (as per physician judgment). Subject in whom antiplatelet, anticoagulant or thrombolytic therapy is contraindicated or hypersensitive. Subject has a known allergy to contrast agents or medications used to perform a coronary intervention that cannot be adequately pre-treated, including, but not limited to, sirolimus, paclitaxel, aspirin, heparin, clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor. Subject has a known allergy to urethane, nylon, or silicone. Myocardial infarction within 60 days before enrollment. History of stroke/TIA within 60 days before enrollment. LVEF <30%. Subject is confined to bed. Subject has a life expectancy less than 12 months. History of thrombolytic therapy within two weeks of enrollment. Patient is a recipient of a heart transplant. Patient is unwilling/not able to return for angiographic catheterization at 6-month follow-up. Women who are pregnant, breast-feeding or intend to become pregnant. Subject is planning to participate in other clinical studies before completing this study. Subject has other medical, social, or psychological problems and is unwilling or unable to comply with procedures specified in the protocol, or may have difficulty returning for follow-up visits as specified by the protocol. Cardiogenic shock (SBP <80mmHg requiring inotropes, IABP, or fluid support). Known allergies to sirolimus, paclitaxel or other components of the used medical devices. Subject with renal insufficiency (creatinine ≥2.0mg/dl) or failure (dialysis-dependent). Subject has suspected or proven COVID-19 positive result at present or within the past 4 weeks of informed consent form. Angiographic Exclusion Criteria: Subject has a planned intervention in the left-main plus two separate major epicardial territories (left-main plus 2 vessel diseases). Target vessel size <2.0 mm or >4.0 mm Target lesion in the left main stem and proximal LAD. The target vessel contains visible thrombus. Aorto-ostial target lesion (within 3 mm of the aorta junction); including all left main disease. Moderate-severe tortuous, calcified, or angulated coronary anatomy of the target vessel that, in the opinion of the Investigator, would result in suboptimal imaging or excessive risk of complication from placement of an IVUS catheter following Clinical Decision. The lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft. Target lesions are located within a bifurcation of the planned treatment of side-branch vessel. Target lesion is located within a previous implanted stent.

Sites / Locations

  • The Prince Charles Hospital
  • Royal Adelaide Hospital
  • Victorian Heart Institute - Monash UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SirPlux™ Duo Dual-API Coated PTCA Balloon Catheter

Arm Description

Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with SirPlux™.

Outcomes

Primary Outcome Measures

Performance Endpoint 1
- Device Success: Defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device without burst below rated burst pressure
Performance Endpoint 2
- Technical Success: Defined as successful lesion crossing, completion of POBA and immediate achievement of <30% residual stenosis (by QCA) of the target lesion upon completion of angiography post investigational device inflation
Performance Endpoint 3
- Procedural Success: Defined as device success or technical success and absence of procedural complications following SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter inflation (ie absence of vessel dissection or loss of TIMI 3 flow)
Angiographic Endpoint (by QCA):
In-segment Late Lumen Loss (LLL)

Secondary Outcome Measures

Safety Endpoint
All-cause death Target Vessel Myocardial Infarction (TVMI). Cardiac death Myocardial Infarction (MI) Emergent Coronary Artery Bypass Graft (CABG) Repeat Target Lesion Revascularization (TLR) (clinically driven) by percutaneous or surgical methods Major Adverse Cardiac Event (MACE) Target Vessel Failure (TVF) Target Lesion Failure (TLF) All revascularizations (TLR, TVR and non-TVR)
Angiographic and IVUS Endpoint
In-segment ( and in balloon) percent diameter stenosis (% diameter stenosis; DS).
Angiographic and IVUS Endpoint
in-segment binary angiographic restenosis (BAR) rate [defined as ≥50% DS].
Angiographic and IVUS Endpoint
• In-segment (and in balloon) Minimum Luminal/Lumen Diameter (MLD)
Angiographic and IVUS Endpoint
• In-segment (and in balloon) Change in IVUS MLA (mm2)
Angiographic and IVUS Endpoint
• In-segment (and in balloon) Change in mean lumen area (mm2)
Angiographic and IVUS Endpoint
• In-segment (and in balloon) Change in percentage atheroma volume
Angiographic and IVUS Endpoint
• In-segment (and in balloon) Serial IVUS remodeling (change in vessel area/volume)

Full Information

First Posted
August 25, 2022
Last Updated
February 2, 2023
Sponsor
Advanced NanoTherapies
Collaborators
Cogent Technologies Corporation, Monash University, Cardiovascular Research Foundation, New York
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1. Study Identification

Unique Protocol Identification Number
NCT05521542
Brief Title
ADVANCEd NanoTherapies Dual Active Pharmacological Ingredient (Dual-API) Drug-Coated Balloon to Treat De-Novo Lesions in Patients With Symptomatic Stable Coronary Artery Disease
Acronym
ADVANCE-DCB
Official Title
A Prospective, Single-arm, Multi-center, Feasibility First-in-human Study to Evaluate Safety and Performance of the SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter to Treat De-novo Lesions in Patients With Symptomatic Stable Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced NanoTherapies
Collaborators
Cogent Technologies Corporation, Monash University, Cardiovascular Research Foundation, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This prospective, single-arm, multi-center, safety and feasibility first-in-human study will evaluate the safety and feasibility of the SirPlux™ Duo Dual-API Coated PTCA Balloon Catheter to treat de-novo lesions between ≥2.25 and ≤4.0 mm in patients with stable symptomatic coronary artery disease.
Detailed Description
The SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter is an investigational medical device to be used to treat de-novo lesions in patients with symptomatic coronary artery disease. In this study, SirPlux Duo™ will be used in subjects undergoing a planned percutaneous coronary intervention. Population to treat will include those with de-novo coronary lesions in vessels with a reference vessel diameter (RVD) of ≥2.25 and ≤4.0 mm and a total lesion length of <35mm with documented symptomatic stable coronary artery disease. The study is a prospective, single-arm, multi-center, safety and feasibility first-in-human study designed to generate descriptive data about the use of SirPlux Duo™. The study primary performance endpoint is device success, technical success and procedural success. The safety primary endpoint (angiographic endpoint) is In-segment Late Lumen Loss (LLL) at 6 months. Other safety secondary clinical and angiographic endpoints (detailed below) will me measured during procedure up to 24 hours after discharge, at 30 days, 6 months, 12 months and 24 months after procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Drug Coated Ballon, DCB, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multi-center, single-arm, feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SirPlux™ Duo Dual-API Coated PTCA Balloon Catheter
Arm Type
Experimental
Arm Description
Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with SirPlux™.
Intervention Type
Device
Intervention Name(s)
SirPlux™ Duo Dual-API Coated PTCA Balloon Catheter
Intervention Description
SirPlux™ Duo Dual-API Coated PTCA Balloon Catheter is a Drug-Coated Balloon to treat de novo lesions in patients with symptomatic stable coronary artery disease
Primary Outcome Measure Information:
Title
Performance Endpoint 1
Description
- Device Success: Defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device without burst below rated burst pressure
Time Frame
(Peri-procedural)
Title
Performance Endpoint 2
Description
- Technical Success: Defined as successful lesion crossing, completion of POBA and immediate achievement of <30% residual stenosis (by QCA) of the target lesion upon completion of angiography post investigational device inflation
Time Frame
(Peri-procedural)
Title
Performance Endpoint 3
Description
- Procedural Success: Defined as device success or technical success and absence of procedural complications following SirPlux Duo™ Dual-API Coated PTCA Balloon Catheter inflation (ie absence of vessel dissection or loss of TIMI 3 flow)
Time Frame
(Peri-procedural)
Title
Angiographic Endpoint (by QCA):
Description
In-segment Late Lumen Loss (LLL)
Time Frame
at 6 months after the procedure
Secondary Outcome Measure Information:
Title
Safety Endpoint
Description
All-cause death Target Vessel Myocardial Infarction (TVMI). Cardiac death Myocardial Infarction (MI) Emergent Coronary Artery Bypass Graft (CABG) Repeat Target Lesion Revascularization (TLR) (clinically driven) by percutaneous or surgical methods Major Adverse Cardiac Event (MACE) Target Vessel Failure (TVF) Target Lesion Failure (TLF) All revascularizations (TLR, TVR and non-TVR)
Time Frame
During procedure up to 24 hours, at 30 days, 6 months, 12 months and 24 months
Title
Angiographic and IVUS Endpoint
Description
In-segment ( and in balloon) percent diameter stenosis (% diameter stenosis; DS).
Time Frame
at 6 months post-procedure
Title
Angiographic and IVUS Endpoint
Description
in-segment binary angiographic restenosis (BAR) rate [defined as ≥50% DS].
Time Frame
at 6 months post-procedure
Title
Angiographic and IVUS Endpoint
Description
• In-segment (and in balloon) Minimum Luminal/Lumen Diameter (MLD)
Time Frame
at 6 months post-procedure
Title
Angiographic and IVUS Endpoint
Description
• In-segment (and in balloon) Change in IVUS MLA (mm2)
Time Frame
at 6 months post-procedure
Title
Angiographic and IVUS Endpoint
Description
• In-segment (and in balloon) Change in mean lumen area (mm2)
Time Frame
at 6 months post-procedure
Title
Angiographic and IVUS Endpoint
Description
• In-segment (and in balloon) Change in percentage atheroma volume
Time Frame
at 6 months post-procedure
Title
Angiographic and IVUS Endpoint
Description
• In-segment (and in balloon) Serial IVUS remodeling (change in vessel area/volume)
Time Frame
at 6 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject is ≥18 years and <90 years old. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. Life expectancy > 1 year. The subject is intended to undergo an angiographic procedure and coronary percutaneous intervention. The subject is an acceptable candidate for treatment in the Investigator's opinion and/or per hospital guidelines. The subject is intended to undergo treatment with a coronary drug-coated balloon. Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure. Men with a female partner of childbearing potential must agree to use condoms plus an additional reliable contraceptive method within 12 months after the index procedure. The subject is able and willing to comply with all assessments in the study, including dual antiplatelet therapy (DAPT), ASA indefinitely, and P2Y12 inhibitor for a minimum of 6 months. The subject shall be under optimal medical therapy for ASCVD, which includes at a minimum high-intensity statin therapy (atorvastatin 40-80 mg/d or rosuvastatin 20-40 mg/d). If statin intolerant, the patient should be treated with a PCSK9 inhibitor, ezetimibe or bempedoic acid. Subject has chronic stable angina or has had an acute coronary syndrome and the cardiac biomarkers have returned to normal Target lesion is located within a de-novo coronary artery located in a native coronary artery with a reference vessel diameter between ≥2.25 mm to ≤4.0mm by visual estimate, with a lesion length of equal greater 15mm to < 35mm. Subject has multiple lesions that meet inclusion and exclusion criteria individually that could be treated with a study device. To be treated with a study device, lesions must be defined as target lesions. A maximum of three (3) lesions could be treated during the index procedure (maximum of 2 target vessels). One (1) non-target lesion can be staged if needed. Target lesions (up tp 2) cannot be staged. One investigational device is to be used per target lesion. Successful pre-dilation with semi and/or non-compliant balloon of the target lesion(s) is defined as no major flow-limiting dissections (Grade C or higher) and ≤30% residual stenosis of the target lesion by a visual estimate on angiography. Adjunctive therapy pre-dilation therapies such as scoring balloon, cutting balloon, and IVL are allowed. Rotablator or similar rotational atherectomy devices are restricted per protocol. Exclusion Criteria: General Exclusion Criteria: Subject has other serious medical illnesses (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months. Subject has current problems with substance abuse. Subject has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. Subject participates in another investigational drug or device clinical study that has not reached its primary endpoint. Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure. Significant target vessel tortuosity or other parameters that could prohibit access to the target lesion. Type A lesions, Chronic total occlusion (CTO) of the target lesion(s) or Thrombolysis In Myocardial Infarction (TIMI) flow < 2. Cardiogenic shock. Subject requires treatment of a coronary lesion(s) involving a bifurcation. Target lesion(s) within native or synthetic vessel grafts. CTO of inflow vessel. Subject has had any major (e.g., cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days before the index procedure or has a planned major surgical procedure or intervention within 30 days of the index procedure. Subject requires treatment of a coronary lesion distal to the target lesion(s) at the time of the enrollment/index procedure. The subject has a known coagulopathy or has a bleeding diathesis, thrombocytopenia (with platelet counts less than 100,000/microliter) or platelets > 400,000/microliter, or international normalized ratio >1.5. Patients on chronic oral anticoagulation medications will be excluded of the study Known renal insufficiency (e.g., serum creatinine >2.5mg/dL, or creatinine clearance (CrCl) ≤30 mL/min). Subject on dialysis, or acute kidney failure (as per physician judgment). Subject in whom antiplatelet, anticoagulant or thrombolytic therapy is contraindicated or hypersensitive. Subject has a known allergy to contrast agents or medications used to perform a coronary intervention that cannot be adequately pre-treated, including, but not limited to, sirolimus, paclitaxel, aspirin, heparin, clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor. Subject has a known allergy to urethane, nylon, or silicone. Myocardial infarction within 60 days before enrollment. History of stroke/TIA within 60 days before enrollment. LVEF <30%. Subject is confined to bed. Subject has a life expectancy less than 12 months. History of thrombolytic therapy within two weeks of enrollment. Patient is a recipient of a heart transplant. Patient is unwilling/not able to return for angiographic catheterization at 6-month follow-up. Women who are pregnant, breast-feeding or intend to become pregnant. Subject is planning to participate in other clinical studies before completing this study. Subject has other medical, social, or psychological problems and is unwilling or unable to comply with procedures specified in the protocol, or may have difficulty returning for follow-up visits as specified by the protocol. Cardiogenic shock (SBP <80mmHg requiring inotropes, IABP, or fluid support). Known allergies to sirolimus, paclitaxel or other components of the used medical devices. Subject with renal insufficiency (creatinine ≥2.0mg/dl) or failure (dialysis-dependent). Subject has suspected or proven COVID-19 positive result at present or within the past 4 weeks of informed consent form. Angiographic Exclusion Criteria: Subject has a planned intervention in the left-main plus two separate major epicardial territories (left-main plus 2 vessel diseases). Target vessel size <2.0 mm or >4.0 mm Target lesion in the left main stem and proximal LAD. The target vessel contains visible thrombus. Aorto-ostial target lesion (within 3 mm of the aorta junction); including all left main disease. Moderate-severe tortuous, calcified, or angulated coronary anatomy of the target vessel that, in the opinion of the Investigator, would result in suboptimal imaging or excessive risk of complication from placement of an IVUS catheter following Clinical Decision. The lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft. Target lesions are located within a bifurcation of the planned treatment of side-branch vessel. Target lesion is located within a previous implanted stent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marwan Berrada-Sounni
Phone
(415) 517-0867
Email
mberrada@advnanot.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Nicholls
Organizational Affiliation
Monash Heart
Official's Role
Study Director
Facility Information:
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maricel Roxas
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
50000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Healy, RN RM
Facility Name
Victorian Heart Institute - Monash University
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryanne Austin

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ADVANCEd NanoTherapies Dual Active Pharmacological Ingredient (Dual-API) Drug-Coated Balloon to Treat De-Novo Lesions in Patients With Symptomatic Stable Coronary Artery Disease

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