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In-stent Coronary Artery RestenosisRESPECT-ISRNCT05093244

Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment

A study testing SeQuent Please ReX and Plain old balloon angioplasty (POBA) in people with In-stent Coronary Artery Restenosis and Coronary Artery Restenosis, run by B. Braun Medical Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SeQuent Please ReX and Plain old balloon angioplasty (POBA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
10 Feb 2023to 10 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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)

Who cannot join

  • 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
Show all 19Show fewer
  • 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%

About this study

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)

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.

Read the 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.

Being tested
SeQuent Please ReX, Plain old balloon angioplasty (POBA)
Keywords
Drug coated balloon catheter, Paclitaxel coated balloon, Rapid exchange balloon tip catheter, Percutaneous transluminal coronary angioplasty, In-stent lesions in coronary arteries
Medical subject headings
Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SeQuent Please ReXDevice

    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).

  • Plain old balloon angioplasty (POBA)Device

    Any commercially available semi-compliant PTCA balloon may be used per the investigator's discretion.

Study groups in NCT05093244
Study groupRoleWhat they receive
SeQuent Please ReXExperimentalDrug coated balloon (DCB) catheter.
Receives: Device: SeQuent Please ReX
Plain old balloon angioplasty (POBA)Active comparatorNot described
Receives: Device: Plain old balloon angioplasty (POBA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months post-procedure

Secondary outcomes (9)

  1. 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.

    Measured: 9 months post-procedure

  2. All death

    Death of subject.

    Measured: 12 months post-procedure and annually thereafter to study completion

  3. Cardiovascular death

    Death resulting from cardiovascular causes.

    Measured: 12 months post-procedure and annually thereafter to study completion

  4. Myocardial infarction (MI)

    Not clearly attributable to a nontarget vessel

    Measured: 12 months post-procedure and annually thereafter to study completion

  5. Major adverse cardiac events (MACE)

    Defined as the composite of all death, clinically-driven TLR, and MI

    Measured: 12 months post-procedure and annually thereafter to study completion

  6. Stent thrombosis

    Early, late, or very late; ARC category of definite or probable

    Measured: 12 months post-procedure and annually thereafter to study completion

  7. 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.

    Measured: 12 months post-procedure and annually thereafter to study completion

  8. 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.

    Measured: 12 months post-procedure and annually thereafter to study completion

  9. 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.

    Measured: Post-procedure (device and lesion success) and at discharge (procedural success)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2021
  2. Study start10 Feb 2023
  3. Primary completion10 Feb 2023
  4. Study completion10 Feb 2023

Why it stopped: Business decision to terminate study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05093244
Sponsor's protocol ID
BIS-CL-5001
Acronym
RESPECT-ISR
Status last verified
Feb 2023
First submitted
7 Oct 2021
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SeQuent Please ReX and Plain old balloon angioplasty (POBA) in people with In-stent Coronary Artery Restenosis and Coronary Artery Restenosis, run by B. Braun Medical Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from target lesion failure (TLF) (time frame: 12 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05093244.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.

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