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In-Stent Restenosis

4
Pipeline Programs
6
Companies
10
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
2
2
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

6 companies ranked by most advanced pipeline stage

Abbott
AbbottABBOTT PARK, IL
4 programs
2
Coronary angioplasty using the paclitaxel-eluting balloonPhase 41 trial
Coronary angioplasty using the paclitaxel-eluting balloonPhase 41 trial
Drug Eluting BalloonN/A1 trial
Optical Coherence TomographyN/A1 trial
Active Trials
NCT05731700Completed51Est. May 2025
NCT04268875Completed307Est. Dec 2022
NCT01239953Unknown190
+1 more trials
Boston Scientific
Boston ScientificCA - Valencia
2 programs
2
AGENT DCBPhase 31 trial
AGENT DCB 40 mmPhase 31 trial
Active Trials
NCT04647253Active Not Recruiting600Est. Sep 2027
NCT06492174Active Not Recruiting20Est. Dec 2027
Medtronic
MedtronicNJ - Phillipsburg
1 program
Medtronic Coronary Drug-Coated Balloon CatheterN/A1 trial
Active Trials
NCT03260517Completed50Est. Aug 2019
Concept Medical
Concept MedicalFL - Tampa
1 program
Sirolimus Drug Coated BalloonN/A1 trial
Active Trials
NCT05908331Recruiting492Est. Jul 2028
Reflow Medical
Reflow MedicalCA - San Clemente
1 program
Drug-eluting Coronary Spur Stent SystemPHASE_11 trial
Active Trials
NCT06117150Active Not Recruiting10Est. Jul 2026
Cordis
CordisFL - Miami Lakes
1 program
Sirolimus-Eluting Bx Velocity® Balloon Expandable StentPHASE_31 trial
Active Trials
NCT00231257Completed384Est. Sep 2009

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
AbbottCoronary angioplasty using the paclitaxel-eluting balloon
AbbottCoronary angioplasty using the paclitaxel-eluting balloon
Boston ScientificAGENT DCB 40 mm
Boston ScientificAGENT DCB
CordisSirolimus-Eluting Bx Velocity® Balloon Expandable Stent
Reflow MedicalDrug-eluting Coronary Spur Stent System
Concept MedicalSirolimus Drug Coated Balloon
AbbottDrug Eluting Balloon
AbbottOptical Coherence Tomography
MedtronicMedtronic Coronary Drug-Coated Balloon Catheter

Clinical Trials (10)

Total enrollment: 2,414 patients across 10 trials

NCT01239940AbbottCoronary angioplasty using the paclitaxel-eluting balloon

RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

Start: Jan 2010310 patients
Phase 4Unknown
NCT01239953AbbottCoronary angioplasty using the paclitaxel-eluting balloon

RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

Start: Jan 2010190 patients
Phase 4Unknown
NCT06492174Boston ScientificAGENT DCB 40 mm

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

Start: Oct 2024Est. completion: Dec 202720 patients
Phase 3Active Not Recruiting
NCT04647253Boston ScientificAGENT DCB

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

Start: May 2021Est. completion: Sep 2027600 patients
Phase 3Active Not Recruiting
NCT00231257CordisSirolimus-Eluting Bx Velocity® Balloon Expandable Stent

Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)

Start: Feb 2003Est. completion: Sep 2009384 patients
Phase 3Completed
NCT06117150Reflow MedicalDrug-eluting Coronary Spur Stent System

Pilot Study of the Coronary Spur Stent for In-stent Restenosis (DEEPER CORONARY)

Start: Jun 2024Est. completion: Jul 202610 patients
Phase 1Active Not Recruiting
NCT05908331Concept MedicalSirolimus Drug Coated Balloon

MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions

Start: Apr 2024Est. completion: Jul 2028492 patients
N/ARecruiting
NCT05731700AbbottDrug Eluting Balloon

CVT-ISR First in Human Trial for Coronary In-Stent Restenosis

Start: Oct 2021Est. completion: May 202551 patients
N/ACompleted
NCT04268875AbbottOptical Coherence Tomography

Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT

Start: Dec 2019Est. completion: Dec 2022307 patients
N/ACompleted
NCT03260517MedtronicMedtronic Coronary Drug-Coated Balloon Catheter

The PREVAIL Study

Start: Oct 2017Est. completion: Aug 201950 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 2,414 patients
6 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.