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

Sponsor

Hemoteq AG (Industry)

Overall Status

Completed

CT.gov ID

NCT02151812

Collaborator

(none)

123

Enrollment

Locations

Arms

62.5

Actual Duration (Months)

10.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Restenosis Coronary Atherosclerosis Coronary Arteriosclerosis	Device: Agent Paclitaxel-coated balloon Device: SeQuent® Please Paclitaxel-coated Balloon	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Aug 13, 2014

Actual Primary Completion Date :

Apr 27, 2017

Actual Study Completion Date :

Oct 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Agent Paclitaxel-coated balloon 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 After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.
Active Comparator: SeQuent Please Paclitaxel-coated balloon 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 After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.

Arm

Intervention/Treatment

Experimental: Agent Paclitaxel-coated balloon

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

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

Active Comparator: SeQuent Please Paclitaxel-coated balloon

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

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

Outcome Measures

Primary Outcome Measures

in-stent late lumen loss [six months]
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 [during index procedure, less 1 hour]
The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30 percent
clinical procedural success rate [within 24 hours of index procedure]
Technical success with no composite of all death and MI noted within 24 hours of the index procedure.
In-stent percent diameter stenosis [6 months post-index procedure]
In-stent percent diameter reduction measured within the borders of the stent
In-segment percent diameter stenosis [6 months post-index procedure]
In-segment percent diameter reduction measured in the stented segment plus 5mm on either side.
In-stent binary restenosis rate [6 months post-index procedure]
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 [6 months post-index procedure]
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 [6 months post-index procedure]
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) [6 months post-index procedure]
In-stent MLD is measured within the borders of the stent.
In-segment minimal lumen diameter (MLD) [6 months post-index procedure]
In-segment MLD is measured in the stented segment plus 5mm on either side.
Target lesion revascularization (TLR) rate [pre-discharge, estim. <10 days]
TLR rate during index in-hospital stay
Target lesion revascularization (TLR) rate [30 days]
Target lesion revascularization (TLR) rate [six months]
Target lesion revascularization (TLR) rate [12 months]
Target lesion revascularization (TLR) rate [24 months]
Target lesion revascularization (TLR) rate [36 months]
Target vessel revascularization (TVR) rate [pre-discharge, estim. <10 days]
TVR rate during index in-hospital stay
Target vessel revascularization (TVR) rate [30 days]
Target vessel revascularization (TVR) rate [six months]
Target vessel revascularization (TVR) rate [12 months]
Target vessel revascularization (TVR) rate [24 months]
Target vessel revascularization (TVR) rate [36 months]
Cardiac, non-cardiac and all death rates [pre-discharge, estim. <10 days]
rates during index in-hospital stay
Cardiac, non-cardiac and all death rates [30 days]
Cardiac, non-cardiac and all death rates [six months]
Cardiac, non-cardiac and all death rates [12 months]
Cardiac, non-cardiac and all death rates [24 months]
Cardiac, non-cardiac and all death rates [36 months]
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) [pre-discharge, estim. <10 days]
rates during index in-hospital stay
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) [30 days]
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) [six months]
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) [12 months]
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) [24 months]
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) [36 months]
Stent thrombosis rate (by ARC definition) [pre-discharge, estim. <10 days]
rates during index in-hospital stay
Stent thrombosis rate (by ARC definition) [30 days]
Stent thrombosis rate (by ARC definition) [six months]
Stent thrombosis rate (by ARC definition) [12 months]
Stent thrombosis rate (by ARC definition) [24 months]
Stent thrombosis rate (by ARC definition) [36 months]
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) [pre-discharge, estim. <10 days]
rates during index in-hospital stay
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) [30 days]
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) [six months]
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) [12 months]
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) [24 months]
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) [36 months]
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [pre-discharge, estim. <10 days]
rates during index in-hospital stay
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [30 days]
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [six months]
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [12 months]
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [24 months]
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [36 months]
Change in Quality of Life [six months]
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 [12 months]
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 [24 months]
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 [36 months]
Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier Saint Joseph Saint Luc de Lyon	Lyon	France	69007
2	Clinique du Millénaire, Montpellier	Montpellier	France	34000
3	CHU Montpellier, Hôpital Arnaud de Villeneuve	Montpellier	France	34090
4	CHU de Nantes, Hopital Laennec	Nantes	France	44093
5	Clinique Saint Hilaire, Rouen	Rouen	France	76000
6	Kerckhoff-Klinik	Bad Nauheim	Germany	61231
7	Charité Universitaetsmedizin Berlin	Berlin	Germany	13353
8	Universitätsklinikum Düsseldorf	Düsseldorf	Germany	40225
9	University Giessen	Giessen	Germany	35392
10	Klinikum Am Steinenberg	Reutlingen	Germany	72764
11	Universitaetsklinikum Rostock	Rostock	Germany	18057
12	Universitaetsklinikum Ulm	Ulm	Germany	89081