NCT02151812 (AGENT-ISR) is a NA clinical trial of Agent Paclitaxel-coated balloon in Coronary Artery Disease, sponsored by Hemoteq AG.

Who is sponsoring NCT02151812?

NCT02151812 is sponsored by Hemoteq AG.

What drugs are being tested in NCT02151812?

Interventions in NCT02151812: Agent Paclitaxel-coated balloon, SeQuent® Please Paclitaxel-coated Balloon.

What condition does NCT02151812 study?

NCT02151812 studies Coronary Artery Disease, Coronary Restenosis, Coronary Atherosclerosis, Coronary Arteriosclerosis.

Is NCT02151812 still recruiting?

NCT02151812 is currently completed. Last updated 23 December 2019.

Last reviewed 2019-12-23 · How we verify

NCT02151812: AGENT-ISR

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)

Completed NA Last updated 23 December 2019

What this trial tests

NA trial testing Agent Paclitaxel-coated balloon in Coronary Artery Disease in 123 participants. Completed in 28 October 2019.

Timeline

13 August 2014

Primary endpoint
27 April 2017

28 October 2019

Quick facts

Lead sponsor	Hemoteq AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	123
Start date	13 August 2014
Primary completion	27 April 2017
Estimated completion	28 October 2019
Sites	12 locations across France, Germany

Drugs / interventions tested

Agent Paclitaxel-coated balloon
SeQuent® Please Paclitaxel-coated Balloon

Conditions studied

Coronary Artery Disease — all drugs for Coronary Artery Disease →
Coronary Restenosis — all drugs for Coronary Restenosis →
Coronary Atherosclerosis — all drugs for Coronary Atherosclerosis →
Coronary Arteriosclerosis — all drugs for Coronary Arteriosclerosis →

Sponsor

Hemoteq AG

Who can join

18 and older, any sex, with Coronary Artery Disease or Coronary Restenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented coronary arteries (in-stent restenosis). The performance will be determined at six months post-procedure by quantitative coronary angiography (QCA) to measure Late Lumen Loss (LLL) in the re-opened stented segment. QCA results will be assessed by an independent, blinded angiographic core lab. Study statistical hypothesis: The loss of in-stent luminal diameter at six months after treatment of the restenosed stent with the Agent™ study device is not larger than the respective LLL after treatment with the SeQuent® Please control devices, i.e. study device is non-inferior to the control device with respect to LLL.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis.
Hamm CW, Dörr O, Woehrle J, Krackhardt F, et al · · 2020 · cited 25× · PMID 31746743 · DOI 10.4244/eij-d-19-00051

Verify or expand the search:

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
NCT07420582 — Antegrade Autologous Blood Reinfusion After CPB · recruiting
NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting

Other Hemoteq AG trials

Trials by the same sponsor.

NCT02013193 — Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02151812 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hemoteq AG
Last refreshed: 23 December 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02151812.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing