Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment

NCT05093244 | Withdrawn DMC FDA Device

• 1 other identifier: BIS-CL-5001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (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

  12 months post-procedure

Secondary Outcomes (9)

• Late lumen loss (LLL)

  9 months post-procedure

• All death

  12 months post-procedure and annually thereafter to study completion

• Cardiovascular death

  12 months post-procedure and annually thereafter to study completion

• Myocardial infarction (MI)

  12 months post-procedure and annually thereafter to study completion

• Major adverse cardiac events (MACE)

  12 months post-procedure and annually thereafter to study completion

Study Arms (2)

SeQuent Please ReX

EXPERIMENTAL

Drug coated balloon (DCB) catheter.

Device: SeQuent Please ReX

Plain old balloon angioplasty (POBA)

ACTIVE COMPARATOR

Device: Plain old balloon angioplasty (POBA)

Interventions

SeQuent Please ReX DEVICE

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).

SeQuent Please ReX

Plain old balloon angioplasty (POBA) DEVICE

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

Plain old balloon angioplasty (POBA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Dissection type C - F

Sponsors & Collaborators

• B. Braun Medical Inc.: lead
• Bright Research Partners: collaborator
• Infraredx: collaborator

MeSH Terms

Conditions

Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jorge Saucedo, MD, MBA

  Froedtert & Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 26, 2021
• Study Start: February 10, 2023
• Primary Completion: February 10, 2023
• Study Completion: February 10, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share