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

NCT02151812 | Completed DMC

• 2 other identifiers: HTQ002-Agent-ISRCIV-13-11-011728
• Study Type: interventional
• Target: 123
• Locations: 2 countries
• Sites: 12

Brief Summary

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.

Conditions

Coronary Artery Disease; Coronary Restenosis; Coronary Atherosclerosis; Coronary Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

• in-stent late lumen loss

  In-stent late lumen loss (LLL) of the treated stented segment after PTCA using the Agent(TM) study device in comparison to the LLL after PTCA using the SeQuent(R) Please control device as measured by QCA at six months post-index procedure.

  six months

Secondary Outcomes (55)

• technical success rate

  during index procedure, less 1 hour

• clinical procedural success rate

  within 24 hours of index procedure

• In-stent percent diameter stenosis

  6 months post-index procedure

• In-segment percent diameter stenosis

  6 months post-index procedure

• In-stent binary restenosis rate

  6 months post-index procedure

Study Arms (2)

Agent Paclitaxel-coated balloon

EXPERIMENTAL

drug-coated balloon dilatation of the index lesion using a single Agent(TM) balloon that completely covers the restenotic lesion

Device: Agent Paclitaxel-coated balloon

SeQuent Please Paclitaxel-coated balloon

ACTIVE COMPARATOR

drug-coated balloon dilatation of the index lesion using a single SeQuent(R) Please balloon that completely covers the restenotic lesion

Device: SeQuent® Please Paclitaxel-coated Balloon

Interventions

Agent Paclitaxel-coated balloon DEVICE

After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.

Agent Paclitaxel-coated balloon

SeQuent® Please Paclitaxel-coated Balloon DEVICE

After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.

SeQuent Please Paclitaxel-coated balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 years of age
• Subject is willing and able to provide informed consent
• Subject is eligible for percutaneous coronary intervention
• Subject is willing to comply with all protocol-required follow-up evaluations
• Women of child-bearing potential must agree to use a reliable method of contraception
• In-stent restenosis in a lesion previously treated with either a drug-eluting or bare metal stent, located in a native coronary artery with a reference vessel diameter ≥ 2.0 mm and ≤ 3.5 mm
• Target lesion length must be ≤ 28 mm (by visual estimate) and must be covered by only one balloon
• Target lesion must have visually estimated stenosis ≥ 70% and \< 100% in asymptomatic patients
• Target lesion must have visually estimated stenosis ≥ 50% and \< 100% in symptomatic patients
• Thrombolysis in Myocardial Infarction (TIMI) grade flow in the target lesion must be ≥ 1
• Target lesion must be successfully pre-dilated.

You may not qualify if:

• Patient has life expectancy of less than 24 months
• Patient with known coronary artery spasm
• Patient with unprotected left main coronary artery disease
• Patient has current problems with substance abuse
• Patient has planned procedure that may cause non-compliance with the protocol or confound data interpretation
• Patient is participating in another investigational drug or device clinical study that has not reached its primary endpoint
• Patient intends to participate in another investigational drug or device clinical study within 12 months after the index procedure
• Woman who is pregnant or nursing
• Left ventricular ejection fraction \< 25%
• Patient had PCI or other coronary interventions within the last 30 days
• Planned PCI or CABG after the index procedure
• Patient to receive other PCI interventions in the target vessel, such as rotablation, laser atherectomy, cutting balloon, DCB, DES, BMS, bioabsorbable scaffold etc.
• Patient to receive DCB in non-target coronary vessels
• Acute MI \< 72h
• Cardiogenic shock

Sponsors & Collaborators

• Hemoteq AG: lead

Study Sites (12)

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Lyon, 69007, France

Location

Clinique du Millénaire, Montpellier

Montpellier, 34000, France

Location

CHU Montpellier, Hôpital Arnaud de Villeneuve

Montpellier, 34090, France

Location

CHU de Nantes, Hopital Laennec

Nantes, 44093, France

Location

Clinique Saint Hilaire, Rouen

Rouen, 76000, France

Location

Kerckhoff-Klinik

Bad Nauheim, 61231, Germany

Location

Charité Universitaetsmedizin Berlin

Berlin, 13353, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

University Giessen

Giessen, 35392, Germany

Location

Klinikum Am Steinenberg

Reutlingen, 72764, Germany

Location

Universitaetsklinikum Rostock

Rostock, 18057, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

Related Publications (1)

• Hamm CW, Dorr O, Woehrle J, Krackhardt F, Ince H, Zeus T, Berland J, Piot C, Roubille F, Schult I, Allocco DJ, Nef H. A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis. EuroIntervention. 2020 Jul 17;16(4):e328-e334. doi: 10.4244/EIJ-D-19-00051.

  PMID: 31746743 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Stenosis

Study Officials

• Christian W. Hamm, MD

  University Giessen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: August 13, 2014
• Primary Completion: April 27, 2017
• Study Completion: October 28, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Locations

FR (5); DE (7)