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Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment (RESPECT-ISR)

Primary Purpose

In-stent Coronary Artery Restenosis, Coronary Artery Restenosis, In-stent Restenosis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SeQuent Please ReX
Plain old balloon angioplasty (POBA)
Sponsored by
B. Braun Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for In-stent Coronary Artery Restenosis focused on measuring Drug coated balloon catheter, Paclitaxel coated balloon, Rapid exchange balloon tip catheter, Percutaneous transluminal coronary angioplasty, In-stent lesions in coronary arteries

Eligibility Criteria

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

INCLUSION CRITERIA:

  1. ISR (>50%) of a metallic coronary stent of any type (BMS or DES)

  2. Symptomatic ischemic heart disease, including:

    • Chronic stable angina (and/or objective evidence of myocardial ischemia on functional study or fractional flow reserve [FFR] measurement) or
    • Acute coronary syndrome (unstable angina or non-ST-elevation myocardial infarction (NSTEMI)), who require elective or urgent percutaneous coronary intervention (PCI)

  3. One or two ISR lesions requiring treatment

    • ISR lesions may be located in two different vessels
    • Additional non-ISR (de novo) lesions are permitted and may be located in the target or other vessels
  4. Target lesion reference vessel diameter is ≥2.0 or ≤4.0 mm by visual estimation
  5. Total lesion length less than or equal to 34 mm by visual estimation (to permit treatment with balloon up to 40 mm)
  6. Male or female, age 18 years or older
  7. Willing to provide written informed consent and written HIPAA authorization prior to initiation of study procedures
  8. Willing to comply with the specified follow-up visits
  9. Willing and able to comply with post-treatment medications (dual antiplatelet therapy (DAPT) followed by life-long aspirin)
  10. Non-target lesions must be treated successfully (i.e., residual diameter stenosis <30% without complications) before proceeding to treatment of ISR lesion(s)

EXCLUSION CRITERIA:

  1. Target lesion has undergone more than two prior stent implant procedures, i.e., more than two layers of stent are present at any segment of target lesion
  2. Presents with ST-elevation myocardial infarction (STEMI)
  3. STEMI within the past 72 hours
  4. Chronic kidney disease, defined as glomerular filtration rate (GFR) <15 ml/min/1.73m^2 on baseline labs
  5. Thrombocytopenia, defined as a platelet count of <50,000 microL on baseline labs
  6. Target lesion is a chronic total occlusion
  7. Bleeding diathesis, coagulopathy, or contraindication to antiplatelet therapy
  8. Target lesion restenosis is within a bio-resorbable scaffold
  9. Target lesion is located within the left main
  10. Pregnant (verified with a urine or blood pregnancy test), breast-feeding, or planning to become pregnant
  11. Severely disabled and/or life expectancy appears limited (≤12 months) according to the investigator's opinion
  12. Known hypersensitivity to paclitaxel and/or resveratrol or any of the product ingredients
  13. Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints

Note: Bifurcation lesions are not excluded; however, the main branch should be treated per randomization, and the side branch should be treated provisionally per current standard of care.

Angiographic Exclusion Criteria:

Subjects must not meet any of the following angiographic exclusion criteria after lesion preparation:

  1. Dissection type C - F
  2. TIMI < III
  3. Residual stenosis >30%

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SeQuent Please ReX

    Plain old balloon angioplasty (POBA)

    Arm Description

    Drug coated balloon (DCB) catheter.

    Outcomes

    Primary Outcome Measures

    Freedom from target lesion failure (TLF)
    TLF is defined as the composite of any of the following events: Clinically-driven target lesion revascularization (TLR) Myocardial infarction (MI; not clearly attributable to a nontarget vessel) Cardiovascular death

    Secondary Outcome Measures

    Late lumen loss (LLL)
    Assessed on the first 100 subjects reaching 9-month follow-up (angiographic cohort). Minimum lumen diameter (MLD) assessed at follow-up angiography minus the MLD assessed immediately after the index procedure. MLDs are measured by qualitative comparative analysis.
    All death
    Death of subject.
    Cardiovascular death
    Death resulting from cardiovascular causes.
    Myocardial infarction (MI)
    Not clearly attributable to a nontarget vessel
    Major adverse cardiac events (MACE)
    Defined as the composite of all death, clinically-driven TLR, and MI
    Stent thrombosis
    Early, late, or very late; ARC category of definite or probable
    Clinically-driven target lesion revascularization (TLR)
    Target lesion revascularization is defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
    Clinically-driven target vessel revascularization (TVR)
    Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
    Device, lesion, and procedural success
    Device success defined as achievement of a final residual stenosis of ≤30% (as determined by the angiographic core lab), using the SeQuent Please ReX or control balloon. Lesion success defined as achievement of a final residual stenosis of ≤0% (as determined by the angiographic core lab), using any device. Procedural success defined as lesion success without the occurrence of major adverse events during the procedure, where "major adverse event" is considered to be an event without the occurrence of in-hospital MI, TVR, or cardiac death.

    Full Information

    First Posted
    October 7, 2021
    Last Updated
    February 10, 2023
    Sponsor
    B. Braun Medical Inc.
    Collaborators
    Bright Research Partners, Infraredx
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05093244
    Brief Title
    Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment
    Acronym
    RESPECT-ISR
    Official Title
    A Prospective, Randomized, Multi-center IDE Study to Assess the SeQuent Please ReX Drug Coated PTCA Balloon Catheter for the Treatment of In-stent Restenosis (RESPECT-ISR)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business decision to terminate study.
    Study Start Date
    February 10, 2023 (Actual)
    Primary Completion Date
    February 10, 2023 (Actual)
    Study Completion Date
    February 10, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    B. Braun Medical Inc.
    Collaborators
    Bright Research Partners, Infraredx

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated.
    Detailed Description
    The investigation is a prospective, randomized, multi-center IDE study comparing the SeQuent Please ReX to plain old balloon angioplasty (POBA). The study will be conducted at up to 30 investigational sites and enroll up to 296 patients with in-stent restenosis of a metallic coronary stent who are suitable candidates for PTCA procedures. After consent and assessment of inclusion and exclusion criteria, eligible patients will be randomized to either the SeQuent Please ReX or POBA arm based on a 2:1 randomization ratio. Subjects will return for follow-up through 5 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    In-stent Coronary Artery Restenosis, Coronary Artery Restenosis, In-stent Restenosis
    Keywords
    Drug coated balloon catheter, Paclitaxel coated balloon, Rapid exchange balloon tip catheter, Percutaneous transluminal coronary angioplasty, In-stent lesions in coronary arteries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be randomized in a 2:1 ratio to either the SeQuent Please ReX or POBA arms, stratified by the presence or absence of baseline diabetes mellitus and acute coronary syndrome (ACS) vs. non-ACS presentation.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SeQuent Please ReX
    Arm Type
    Experimental
    Arm Description
    Drug coated balloon (DCB) catheter.
    Arm Title
    Plain old balloon angioplasty (POBA)
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    SeQuent Please ReX
    Intervention Description
    The SeQuent Please ReX is a conventional rapid exchange balloon tip catheter with a drug-coated balloon (DCB). The surface of the SeQuent Please ReX balloon is coated with paclitaxel, embedded in a soluble matrix (resveratrol).
    Intervention Type
    Device
    Intervention Name(s)
    Plain old balloon angioplasty (POBA)
    Intervention Description
    Any commercially available semi-compliant PTCA balloon may be used per the investigator's discretion.
    Primary Outcome Measure Information:
    Title
    Freedom from target lesion failure (TLF)
    Description
    TLF is defined as the composite of any of the following events: Clinically-driven target lesion revascularization (TLR) Myocardial infarction (MI; not clearly attributable to a nontarget vessel) Cardiovascular death
    Time Frame
    12 months post-procedure
    Secondary Outcome Measure Information:
    Title
    Late lumen loss (LLL)
    Description
    Assessed on the first 100 subjects reaching 9-month follow-up (angiographic cohort). Minimum lumen diameter (MLD) assessed at follow-up angiography minus the MLD assessed immediately after the index procedure. MLDs are measured by qualitative comparative analysis.
    Time Frame
    9 months post-procedure
    Title
    All death
    Description
    Death of subject.
    Time Frame
    12 months post-procedure and annually thereafter to study completion
    Title
    Cardiovascular death
    Description
    Death resulting from cardiovascular causes.
    Time Frame
    12 months post-procedure and annually thereafter to study completion
    Title
    Myocardial infarction (MI)
    Description
    Not clearly attributable to a nontarget vessel
    Time Frame
    12 months post-procedure and annually thereafter to study completion
    Title
    Major adverse cardiac events (MACE)
    Description
    Defined as the composite of all death, clinically-driven TLR, and MI
    Time Frame
    12 months post-procedure and annually thereafter to study completion
    Title
    Stent thrombosis
    Description
    Early, late, or very late; ARC category of definite or probable
    Time Frame
    12 months post-procedure and annually thereafter to study completion
    Title
    Clinically-driven target lesion revascularization (TLR)
    Description
    Target lesion revascularization is defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
    Time Frame
    12 months post-procedure and annually thereafter to study completion
    Title
    Clinically-driven target vessel revascularization (TVR)
    Description
    Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
    Time Frame
    12 months post-procedure and annually thereafter to study completion
    Title
    Device, lesion, and procedural success
    Description
    Device success defined as achievement of a final residual stenosis of ≤30% (as determined by the angiographic core lab), using the SeQuent Please ReX or control balloon. Lesion success defined as achievement of a final residual stenosis of ≤0% (as determined by the angiographic core lab), using any device. Procedural success defined as lesion success without the occurrence of major adverse events during the procedure, where "major adverse event" is considered to be an event without the occurrence of in-hospital MI, TVR, or cardiac death.
    Time Frame
    Post-procedure (device and lesion success) and at discharge (procedural success)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    INCLUSION CRITERIA: ISR (>50%) of a metallic coronary stent of any type (BMS or DES) Symptomatic ischemic heart disease, including: Chronic stable angina (and/or objective evidence of myocardial ischemia on functional study or fractional flow reserve [FFR] measurement) or Acute coronary syndrome (unstable angina or non-ST-elevation myocardial infarction (NSTEMI)), who require elective or urgent percutaneous coronary intervention (PCI) One or two ISR lesions requiring treatment ISR lesions may be located in two different vessels Additional non-ISR (de novo) lesions are permitted and may be located in the target or other vessels Target lesion reference vessel diameter is ≥2.0 or ≤4.0 mm by visual estimation Total lesion length less than or equal to 34 mm by visual estimation (to permit treatment with balloon up to 40 mm) Male or female, age 18 years or older Willing to provide written informed consent and written HIPAA authorization prior to initiation of study procedures Willing to comply with the specified follow-up visits Willing and able to comply with post-treatment medications (dual antiplatelet therapy (DAPT) followed by life-long aspirin) Non-target lesions must be treated successfully (i.e., residual diameter stenosis <30% without complications) before proceeding to treatment of ISR lesion(s) EXCLUSION CRITERIA: Target lesion has undergone more than two prior stent implant procedures, i.e., more than two layers of stent are present at any segment of target lesion Presents with ST-elevation myocardial infarction (STEMI) STEMI within the past 72 hours Chronic kidney disease, defined as glomerular filtration rate (GFR) <15 ml/min/1.73m^2 on baseline labs Thrombocytopenia, defined as a platelet count of <50,000 microL on baseline labs Target lesion is a chronic total occlusion Bleeding diathesis, coagulopathy, or contraindication to antiplatelet therapy Target lesion restenosis is within a bio-resorbable scaffold Target lesion is located within the left main Pregnant (verified with a urine or blood pregnancy test), breast-feeding, or planning to become pregnant Severely disabled and/or life expectancy appears limited (≤12 months) according to the investigator's opinion Known hypersensitivity to paclitaxel and/or resveratrol or any of the product ingredients Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Bifurcation lesions are not excluded; however, the main branch should be treated per randomization, and the side branch should be treated provisionally per current standard of care. Angiographic Exclusion Criteria: Subjects must not meet any of the following angiographic exclusion criteria after lesion preparation: Dissection type C - F TIMI < III Residual stenosis >30%
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jorge Saucedo, MD, MBA
    Organizational Affiliation
    Froedtert & Medical College of Wisconsin
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment

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