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

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.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Restenosis; In-stent Restenosis; In-stent Coronary Artery Restenosis
• Intervention / Treatment: Device: SeQuent Please ReX; Device: Plain old balloon angioplasty (POBA)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Ortiz; Phone Number: 386-281-2250; Email: katherine.ortiz@bbraunusa.com
• Study Contact Backup: Name: Melissa Ingram, PhD; Phone Number: 612-345-4544; Email: melissa@brightresearchpartners.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SeQuent Please ReX; Drug coated balloon (DCB) catheter.	Device: SeQuent Please ReX; 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).
ACTIVE_COMPARATOR: Plain old balloon angioplasty (POBA)	Device: Plain old balloon angioplasty (POBA); Any commercially available semi-compliant PTCA balloon may be used per the investigator's discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months post-procedure
All death	Death of subject.	12 months post-procedure and annually thereafter to study completion
Cardiovascular death	Death resulting from cardiovascular causes.	12 months post-procedure and annually thereafter to study completion
Myocardial infarction (MI)	Not clearly attributable to a nontarget vessel	12 months post-procedure and annually thereafter to study completion
Major adverse cardiac events (MACE)	Defined as the composite of all death, clinically-driven TLR, and MI	12 months post-procedure and annually thereafter to study completion
Stent thrombosis	Early, late, or very late; ARC category of definite or probable	12 months post-procedure and annually thereafter to study completion
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.	12 months post-procedure and annually thereafter to study completion
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.	12 months post-procedure and annually thereafter to study completion
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.	Post-procedure (device and lesion success) and at discharge (procedural success)

Collaborators and Investigators

• Sponsor: B. Braun Medical Inc.
• Collaborators: Infraredx; Bright Research Partners
• Investigators: Principal Investigator: Jorge Saucedo, MD, MBA, Froedtert & Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2023
• Primary Completion (ACTUAL): February 10, 2023
• Study Completion (ACTUAL): February 10, 2023

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (ACTUAL): October 26, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous transluminal coronary angioplasty; Drug coated balloon catheter; Paclitaxel coated balloon; Rapid exchange balloon tip catheter; In-stent lesions in coronary arteries
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: BIS-CL-5001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes