A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) (AGENT IDE)
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ClinicalTrials.gov Identifier: NCT04647253 |
Recruitment Status :
Active, not recruiting
First Posted : November 30, 2020
Last Update Posted : April 1, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | November 23, 2020 | ||||
First Posted Date ICMJE | November 30, 2020 | ||||
Last Update Posted Date | April 1, 2024 | ||||
Actual Study Start Date ICMJE | May 11, 2021 | ||||
Actual Primary Completion Date | October 2, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Target Lesion Failure Rate [ Time Frame: 12-month ] The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death
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Original Primary Outcome Measures ICMJE | Not Provided | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) | ||||
Official Title ICMJE | AGENT IDE: A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) | ||||
Brief Summary | AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Prospective, Randomized (2:1), Multicenter Trial Masking: Single (Participant)Primary Purpose: Treatment |
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Condition ICMJE | In-Stent Restenosis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
600 | ||||
Original Enrollment ICMJE | Not Provided | ||||
Estimated Study Completion Date ICMJE | September 2027 | ||||
Actual Primary Completion Date | October 2, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Clinical Inclusion Criteria
Angiographic Inclusion Criteria (visual estimate)
Clinical Exclusion Criteria
Angiographic Exclusion Criteria (visual estimate)
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04647253 | ||||
Other Study ID Numbers ICMJE | S2358 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Boston Scientific Corporation | ||||
Original Responsible Party | [Redacted] | ||||
Current Study Sponsor ICMJE | Boston Scientific Corporation | ||||
Original Study Sponsor ICMJE | [Redacted] | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Boston Scientific Corporation | ||||
Verification Date | March 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |