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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hemoteq AG
Sponsor:
Information provided by (Responsible Party):
Hemoteq AG
ClinicalTrials.gov Identifier:
NCT02151812
First received: May 28, 2014
Last updated: August 15, 2014
Last verified: August 2014
  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 Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    In-stent percent diameter reduction measured within the borders of the stent

  • In-segment percent diameter stenosis [ Time Frame: 6 months post-index procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    In-stent MLD is measured within the borders of the stent.

  • In-segment minimal lumen diameter (MLD) [ Time Frame: 6 months post-index procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    TLR rate during index in-hospital stay

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

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

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

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

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

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

  • Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [ Time Frame: six months ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Change in Quality of Life [ Time Frame: six months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline


Estimated Enrollment: 122
Study Start Date: August 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: September 2015 (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-releasing 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 Catheter
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
Genders Eligible for Study:   Both
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
CHU de Nantes, Hopital Laennec Recruiting
Nantes, France, 44093
Contact: Patrice Guerin, MD    +33 240165592    patrice.guerin@chu-nantes.fr   
Principal Investigator: Patrice Guerin, MD         
Germany
University Giessen Not yet recruiting
Giessen, Germany, 35392
Contact: Christian W. Hamm, MD    +49 641-98542101    christian.hamm@innere.med.uni-giessen.de   
Contact: Holger Nef, MD    +49 641-98542101    holger.nef@innere.med.uni-giessen.de   
Principal Investigator: Christian W. Hamm, MD         
Sponsors and Collaborators
Hemoteq AG
Investigators
Principal Investigator: Christian W. Hamm, MD University Giessen, Germany
  More Information

No publications provided

Responsible Party: Hemoteq AG
ClinicalTrials.gov Identifier: NCT02151812     History of Changes
Other Study ID Numbers: HTQ002-Agent-ISR, CIV-13-11-011728
Study First Received: May 28, 2014
Last Updated: August 15, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on September 16, 2014