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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hemoteq AG
ClinicalTrials.gov Identifier:
NCT02151812
First received: May 28, 2014
Last updated: May 25, 2016
Last verified: May 2016
  Purpose

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 Intervention
Coronary Artery Disease Coronary Restenosis Coronary Atherosclerosis Coronary Arteriosclerosis Device: Agent Paclitaxel-coated balloon Device: SeQuent® Please Paclitaxel-coated Balloon

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by Hemoteq AG:

Primary Outcome Measures:
  • in-stent late lumen loss [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months post-index procedure ]
    In-stent percent diameter reduction measured within the borders of the stent

  • In-segment percent diameter stenosis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 6 months post-index procedure ]
    In-stent MLD is measured within the borders of the stent.

  • In-segment minimal lumen diameter (MLD) [ Time Frame: 6 months post-index procedure ]
    In-segment MLD is measured in the stented segment plus 5mm on either side.

  • Target lesion revascularization (TLR) rate [ Time Frame: pre-discharge, estim. <10 days ]
    TLR rate during index in-hospital stay

  • Target lesion revascularization (TLR) rate [ Time Frame: 30 days ]
  • Target lesion revascularization (TLR) rate [ Time Frame: six months ]
  • Target lesion revascularization (TLR) rate [ Time Frame: 12 months ]
  • Target lesion revascularization (TLR) rate [ Time Frame: 24 months ]
  • Target lesion revascularization (TLR) rate [ Time Frame: 36 months ]
  • Target vessel revascularization (TVR) rate [ Time Frame: pre-discharge, estim. <10 days ]
    TVR rate during index in-hospital stay

  • Target vessel revascularization (TVR) rate [ Time Frame: 30 days ]
  • Target vessel revascularization (TVR) rate [ Time Frame: six months ]
  • Target vessel revascularization (TVR) rate [ Time Frame: 12 months ]
  • Target vessel revascularization (TVR) rate [ Time Frame: 24 months ]
  • Target vessel revascularization (TVR) rate [ Time Frame: 36 months ]
  • Cardiac, non-cardiac and all death rates [ Time Frame: pre-discharge, estim. <10 days ]
    rates during index in-hospital stay

  • Cardiac, non-cardiac and all death rates [ Time Frame: 30 days ]
  • Cardiac, non-cardiac and all death rates [ Time Frame: six months ]
  • Cardiac, non-cardiac and all death rates [ Time Frame: 12 months ]
  • Cardiac, non-cardiac and all death rates [ Time Frame: 24 months ]
  • Cardiac, non-cardiac and all death rates [ Time Frame: 36 months ]
  • Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) [ Time Frame: pre-discharge, estim. <10 days ]
    rates during index in-hospital stay

  • Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) [ Time Frame: 30 days ]
  • Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) [ Time Frame: six months ]
  • Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) [ Time Frame: 12 months ]
  • Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) [ Time Frame: 24 months ]
  • Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) [ Time Frame: 36 months ]
  • Stent thrombosis rate (by ARC definition) [ Time Frame: pre-discharge, estim. <10 days ]
    rates during index in-hospital stay

  • Stent thrombosis rate (by ARC definition) [ Time Frame: 30 days ]
  • Stent thrombosis rate (by ARC definition) [ Time Frame: six months ]
  • Stent thrombosis rate (by ARC definition) [ Time Frame: 12 months ]
  • Stent thrombosis rate (by ARC definition) [ Time Frame: 24 months ]
  • Stent thrombosis rate (by ARC definition) [ Time Frame: 36 months ]
  • Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) [ Time Frame: pre-discharge, estim. <10 days ]
    rates during index in-hospital stay

  • Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) [ Time Frame: 30 days ]
  • Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) [ Time Frame: six months ]
  • Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) [ Time Frame: 12 months ]
  • Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) [ Time Frame: 24 months ]
  • Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) [ Time Frame: 36 months ]
  • Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [ Time Frame: pre-discharge, estim. <10 days ]
    rates during index in-hospital stay

  • Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [ Time Frame: 30 days ]
  • Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [ Time Frame: six months ]
  • Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [ Time Frame: 12 months ]
  • Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [ Time Frame: 24 months ]
  • Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [ Time Frame: 36 months ]
  • Change in Quality of Life [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Enrollment: 123
Study Start Date: August 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02151812

Locations
France
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Lyon, France, 69007
Clinique du Millénaire, Montpellier
Montpellier, France, 34000
CHU Montpellier, Hôpital Arnaud de Villeneuve
Montpellier, France, 34090
CHU de Nantes, Hopital Laennec
Nantes, France, 44093
Clinique Saint Hilaire, Rouen
Rouen, France, 76000
Germany
Kerckhoff-Klinik
Bad Nauheim, Germany, 61231
Charité Universitaetsmedizin Berlin
Berlin, Germany, 13353
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
University Giessen
Giessen, Germany, 35392
Klinikum Am Steinenberg
Reutlingen, Germany, 72764
Universitaetsklinikum Rostock
Rostock, Germany, 18057
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
Hemoteq AG
Investigators
Principal Investigator: Christian W. Hamm, MD University Giessen, Germany
  More Information

Responsible Party: Hemoteq AG
ClinicalTrials.gov Identifier: NCT02151812     History of Changes
Other Study ID Numbers: HTQ002-Agent-ISR
CIV-13-11-011728 ( Other Identifier: EUDAMED )
Study First Received: May 28, 2014
Last Updated: May 25, 2016

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Arteriosclerosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 22, 2017