WithdrawnNot Applicable

Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment

Stopped: Business decision to terminate study.

0Started 2023-02-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ISR (\>50%) of a metallic coronary stent of any type (BMS or DES)
✓. Symptomatic ischemic heart disease, including:
✓. One or two ISR lesions requiring treatment
✓. 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

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

What they're measuring

Freedom from target lesion failure (TLF)

Timeframe: 12 months post-procedure

Trial details

NCT IDNCT05093244

SponsorB. Braun Medical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-10

View on ClinicalTrials.gov More In-stent Coronary Artery Restenosis trials