# A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)

> **NCT04647253** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Boston Scientific Corporation** · enrollment: 600 (actual)

## Conditions studied

- In-Stent Restenosis

## Interventions

- **DEVICE:** AGENT DCB
- **DEVICE:** PTCA balloon catheter

## Key facts

- **NCT ID:** NCT04647253
- **Lead sponsor:** Boston Scientific Corporation
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2021-05-11
- **Primary completion:** 2023-10-02
- **Final completion:** 2027-09
- **Target enrollment:** 600 (ACTUAL)
- **Last updated:** 2026-04-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04647253

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04647253, "A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT04647253. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
