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

Primary Purpose

Coronary Artery Disease, Coronary Restenosis, Coronary Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Agent Paclitaxel-coated balloon
SeQuent® Please Paclitaxel-coated Balloon
Sponsored by
Hemoteq AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Known allergies against Paclitaxel or other components of the used medical devices
  • Known hypersensitivity or contraindication for contrast dye that cannot be adequately pre-medicated
  • Intolerance to antiplatelet drugs, anticoagulants required for the procedure
  • Platelet count < 100k/mm3 or > 500k/mm3
  • Patient with renal failure with a serum creatinine of > 2.5mg/dL who is receiving dialysis or chronic immunosuppressant therapy
  • Target lesion is located within a bifurcation involving a major side branch > 2 mm in diameter
  • Target lesion is located within a saphenous vein graft or an arterial graft
  • Target lesion with TIMI grade flow = 0 (total occlusion)
  • Thrombus present in the target vessel
  • > 50% stenosis of an additional lesion proximal or distal to the target lesion

Sites / Locations

  • Centre Hospitalier Saint Joseph Saint Luc de Lyon
  • Clinique du Millénaire, Montpellier
  • CHU Montpellier, Hôpital Arnaud de Villeneuve
  • CHU de Nantes, Hopital Laennec
  • Clinique Saint Hilaire, Rouen
  • Kerckhoff-Klinik
  • Charité Universitaetsmedizin Berlin
  • Universitätsklinikum Düsseldorf
  • University Giessen
  • Klinikum Am Steinenberg
  • Universitaetsklinikum Rostock
  • Universitaetsklinikum Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Agent Paclitaxel-coated balloon

SeQuent Please Paclitaxel-coated balloon

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

technical success rate
The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30 percent
clinical procedural success rate
Technical success with no composite of all death and MI noted within 24 hours of the index procedure.
In-stent percent diameter stenosis
In-stent percent diameter reduction measured within the borders of the stent
In-segment percent diameter stenosis
In-segment percent diameter reduction measured in the stented segment plus 5mm on either side.
In-stent binary restenosis rate
In-stent binary restenosis is defined as ≥50% luminal narrowing within the borders of the stent observed at follow-up QCA.
In-segment binary restenosis rate
In-segment binary restenosis is defined as ≥50% luminal narrowing in the stented segment plus 5mm on either side observed at follow-up QCA.
In-segment late lumen loss
In-segment late lumen loss is the in-segment minimal lumen diameter (MLD) post index procedure minus the in-segment MLD at 6 months follow-up as determined by QCA.
In-stent minimal lumen diameter (MLD)
In-stent MLD is measured within the borders of the stent.
In-segment minimal lumen diameter (MLD)
In-segment MLD is measured in the stented segment plus 5mm on either side.
Target lesion revascularization (TLR) rate
TLR rate during index in-hospital stay
Target lesion revascularization (TLR) rate
Target lesion revascularization (TLR) rate
Target lesion revascularization (TLR) rate
Target lesion revascularization (TLR) rate
Target lesion revascularization (TLR) rate
Target vessel revascularization (TVR) rate
TVR rate during index in-hospital stay
Target vessel revascularization (TVR) rate
Target vessel revascularization (TVR) rate
Target vessel revascularization (TVR) rate
Target vessel revascularization (TVR) rate
Target vessel revascularization (TVR) rate
Cardiac, non-cardiac and all death rates
rates during index in-hospital stay
Cardiac, non-cardiac and all death rates
Cardiac, non-cardiac and all death rates
Cardiac, non-cardiac and all death rates
Cardiac, non-cardiac and all death rates
Cardiac, non-cardiac and all death rates
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
rates during index in-hospital stay
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
Stent thrombosis rate (by ARC definition)
rates during index in-hospital stay
Stent thrombosis rate (by ARC definition)
Stent thrombosis rate (by ARC definition)
Stent thrombosis rate (by ARC definition)
Stent thrombosis rate (by ARC definition)
Stent thrombosis rate (by ARC definition)
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
rates during index in-hospital stay
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
rates during index in-hospital stay
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
Change in Quality of Life
Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline
Change in Quality of Life
Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline
Change in Quality of Life
Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline
Change in Quality of Life
Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline

Full Information

First Posted
May 28, 2014
Last Updated
December 20, 2019
Sponsor
Hemoteq AG
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1. Study Identification

Unique Protocol Identification Number
NCT02151812
Brief Title
Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)
Acronym
AGENT-ISR
Official Title
A Prospective Randomized Multicenter Non-inferiority Clinical Study to Determine the Safety and Performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter (Hemoteq) Compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter (B.Braun) for the Treatment of Coronary In-Stent Restenosis (AGENT-ISR)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 13, 2014 (Actual)
Primary Completion Date
April 27, 2017 (Actual)
Study Completion Date
October 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hemoteq AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Restenosis, Coronary Atherosclerosis, Coronary Arteriosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Agent Paclitaxel-coated balloon
Arm Type
Experimental
Arm Description
drug-coated balloon dilatation of the index lesion using a single Agent(TM) balloon that completely covers the restenotic lesion
Arm Title
SeQuent Please Paclitaxel-coated balloon
Arm Type
Active Comparator
Arm Description
drug-coated balloon dilatation of the index lesion using a single SeQuent(R) Please balloon that completely covers the restenotic lesion
Intervention Type
Device
Intervention Name(s)
Agent Paclitaxel-coated balloon
Intervention Description
After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.
Intervention Type
Device
Intervention Name(s)
SeQuent® Please Paclitaxel-coated Balloon
Intervention Description
After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.
Primary Outcome Measure Information:
Title
in-stent late lumen loss
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
technical success rate
Description
The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30 percent
Time Frame
during index procedure, less 1 hour
Title
clinical procedural success rate
Description
Technical success with no composite of all death and MI noted within 24 hours of the index procedure.
Time Frame
within 24 hours of index procedure
Title
In-stent percent diameter stenosis
Description
In-stent percent diameter reduction measured within the borders of the stent
Time Frame
6 months post-index procedure
Title
In-segment percent diameter stenosis
Description
In-segment percent diameter reduction measured in the stented segment plus 5mm on either side.
Time Frame
6 months post-index procedure
Title
In-stent binary restenosis rate
Description
In-stent binary restenosis is defined as ≥50% luminal narrowing within the borders of the stent observed at follow-up QCA.
Time Frame
6 months post-index procedure
Title
In-segment binary restenosis rate
Description
In-segment binary restenosis is defined as ≥50% luminal narrowing in the stented segment plus 5mm on either side observed at follow-up QCA.
Time Frame
6 months post-index procedure
Title
In-segment late lumen loss
Description
In-segment late lumen loss is the in-segment minimal lumen diameter (MLD) post index procedure minus the in-segment MLD at 6 months follow-up as determined by QCA.
Time Frame
6 months post-index procedure
Title
In-stent minimal lumen diameter (MLD)
Description
In-stent MLD is measured within the borders of the stent.
Time Frame
6 months post-index procedure
Title
In-segment minimal lumen diameter (MLD)
Description
In-segment MLD is measured in the stented segment plus 5mm on either side.
Time Frame
6 months post-index procedure
Title
Target lesion revascularization (TLR) rate
Description
TLR rate during index in-hospital stay
Time Frame
pre-discharge, estim. <10 days
Title
Target lesion revascularization (TLR) rate
Time Frame
30 days
Title
Target lesion revascularization (TLR) rate
Time Frame
six months
Title
Target lesion revascularization (TLR) rate
Time Frame
12 months
Title
Target lesion revascularization (TLR) rate
Time Frame
24 months
Title
Target lesion revascularization (TLR) rate
Time Frame
36 months
Title
Target vessel revascularization (TVR) rate
Description
TVR rate during index in-hospital stay
Time Frame
pre-discharge, estim. <10 days
Title
Target vessel revascularization (TVR) rate
Time Frame
30 days
Title
Target vessel revascularization (TVR) rate
Time Frame
six months
Title
Target vessel revascularization (TVR) rate
Time Frame
12 months
Title
Target vessel revascularization (TVR) rate
Time Frame
24 months
Title
Target vessel revascularization (TVR) rate
Time Frame
36 months
Title
Cardiac, non-cardiac and all death rates
Description
rates during index in-hospital stay
Time Frame
pre-discharge, estim. <10 days
Title
Cardiac, non-cardiac and all death rates
Time Frame
30 days
Title
Cardiac, non-cardiac and all death rates
Time Frame
six months
Title
Cardiac, non-cardiac and all death rates
Time Frame
12 months
Title
Cardiac, non-cardiac and all death rates
Time Frame
24 months
Title
Cardiac, non-cardiac and all death rates
Time Frame
36 months
Title
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
Description
rates during index in-hospital stay
Time Frame
pre-discharge, estim. <10 days
Title
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
Time Frame
30 days
Title
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
Time Frame
six months
Title
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
Time Frame
12 months
Title
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
Time Frame
24 months
Title
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
Time Frame
36 months
Title
Stent thrombosis rate (by ARC definition)
Description
rates during index in-hospital stay
Time Frame
pre-discharge, estim. <10 days
Title
Stent thrombosis rate (by ARC definition)
Time Frame
30 days
Title
Stent thrombosis rate (by ARC definition)
Time Frame
six months
Title
Stent thrombosis rate (by ARC definition)
Time Frame
12 months
Title
Stent thrombosis rate (by ARC definition)
Time Frame
24 months
Title
Stent thrombosis rate (by ARC definition)
Time Frame
36 months
Title
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
Description
rates during index in-hospital stay
Time Frame
pre-discharge, estim. <10 days
Title
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
Time Frame
30 days
Title
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
Time Frame
six months
Title
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
Time Frame
12 months
Title
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
Time Frame
24 months
Title
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
Time Frame
36 months
Title
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
Description
rates during index in-hospital stay
Time Frame
pre-discharge, estim. <10 days
Title
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
Time Frame
30 days
Title
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
Time Frame
six months
Title
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
Time Frame
12 months
Title
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
Time Frame
24 months
Title
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
Time Frame
36 months
Title
Change in Quality of Life
Description
Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline
Time Frame
six months
Title
Change in Quality of Life
Description
Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline
Time Frame
12 months
Title
Change in Quality of Life
Description
Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline
Time Frame
24 months
Title
Change in Quality of Life
Description
Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Known allergies against Paclitaxel or other components of the used medical devices Known hypersensitivity or contraindication for contrast dye that cannot be adequately pre-medicated Intolerance to antiplatelet drugs, anticoagulants required for the procedure Platelet count < 100k/mm3 or > 500k/mm3 Patient with renal failure with a serum creatinine of > 2.5mg/dL who is receiving dialysis or chronic immunosuppressant therapy Target lesion is located within a bifurcation involving a major side branch > 2 mm in diameter Target lesion is located within a saphenous vein graft or an arterial graft Target lesion with TIMI grade flow = 0 (total occlusion) Thrombus present in the target vessel > 50% stenosis of an additional lesion proximal or distal to the target lesion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian W. Hamm, MD
Organizational Affiliation
University Giessen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Saint Joseph Saint Luc de Lyon
City
Lyon
ZIP/Postal Code
69007
Country
France
Facility Name
Clinique du Millénaire, Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
CHU Montpellier, Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
CHU de Nantes, Hopital Laennec
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Clinique Saint Hilaire, Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Kerckhoff-Klinik
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charité Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
University Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Klinikum Am Steinenberg
City
Reutlingen
ZIP/Postal Code
72764
Country
Germany
Facility Name
Universitaetsklinikum Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
31746743
Citation
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.
Results Reference
derived

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

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