BIO REsponse Adapted Combination Therapy Pilot Study

NCT ID: NCT03547986

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-09
• Study Completion Date: 2024-03-31

Brief Summary

Both drug-coated balloon and stents have been used for a number of years to treat subjects with Peripheral Artery Disease (PAD) and are recognized as very good treatment methods. However, due to a higher risk of blood clot formation, requiring a longer anticoagulant treatment, and the challenge of treating re growth of tissue extending through the metal mesh of the stent, the physicians try to reserve stent placement to situation where it's really needed, in case of flow-limiting vessel dissection or acute re-narrowing.

The purpose of this study is to evaluate the utility of several procedural diagnostic techniques in helping the physicians to better decide whether a stent is needed or not.

The study will also estimate the safety and efficacy of Passeo-18 Lux drug-coated balloon associated to Pulsar 18 bare metal stent when and where needed to treat PAD

Detailed Description

The REACT treatment concept aims at minimizing the metal burden, combining Passeo-18 Lux Drug-Coated Balloon (DCB) with Pulsar-18 thin struts bare metal stent, as low as reasonably achievable (ALARA), while benefiting from the antirestenotic properties of Paclitaxel. However, in order to optimally apply this selective stenting approach, it is needed to clearly identify when a stent is indicated. Angiographic images, even with additional projections, are sometimes insufficient to clearly determine if a dissection is flow-limiting and the subsequent stent requirement. There is currently no definition nor validated method to define flow-limiting dissection in the peripheral arteries. Even though it has been widely used, the classification developed by the National Heart, Lung, and Blood Institute to grade coronary artery dissection as A to F19, based on angiographic appearance cannot be extrapolated to peripheral arteries.

Therefore, the purpose of the study is to evaluate the incremental value of several adjunctive procedural assessments to standard angiography to identify flow-limiting dissection and residual stenosis, and better inform the operator on the stent requirement. In addition, the study will evaluate the safety and efficacy of the REACT algorithm.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Duplex Ultrasound (DUS)

Standard angiography and DUS are performed on the same patients (paired data)

Group Type: EXPERIMENTAL

Duplex Ultrasound (DUS)

Intervention Type: DIAGNOSTIC_TEST

Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Duplex Ultrasound

IVUS with Intraarterial pressure measurement (IAP)

Standard angiography and Intra-Vascular Ultrasound (IVUS) with Intraarterial pressure measurement (IAP) are performed on the same patients (paired data)

Group Type: EXPERIMENTAL

IVUS with Intraarterial pressure measurement (IAP) if needed

Intervention Type: DIAGNOSTIC_TEST

Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Intra-vascular ultrasound associated to Intraarterial pressure measurement if needed

Interventions

Duplex Ultrasound (DUS)

Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Duplex Ultrasound

Intervention Type: DIAGNOSTIC_TEST

IVUS with Intraarterial pressure measurement (IAP) if needed

Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Intra-vascular ultrasound associated to Intraarterial pressure measurement if needed

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Procedural diagnostic with Duplex Ultrasound (DUS); Procedural diagnostic with IVUS and Intraarterial pressure measurement (IAP)

Eligibility Criteria

Inclusion Criteria

• Subject has provided written informed consent before any study specific test or procedure and is willing and able to comply with the required follow-up visits and procedures
• Subject has a chronic, symptomatic lower limb ischemia defined as Rutherford categories 2 to 4

Angiographic criteria:

• Single lesion or consecutive single lesions with a healthy segment(s) of ≤ 2cm in-between
• De novo, restenotic or (re)occluded lesion(s) post Percutaneous Transluminal Angioplasty in the native superficial femoral artery (SFA) and or the proximal popliteal artery (PPA)
• Lesion(s) must be located at least 1 cm distal to the profunda femoris artery and at least 3 cm above the knee joint (radiographic joint space)
• Degree of stenosis ≥70% by visual angiographic assessment
• Vessel diameter ≥ 4 and ≤ 7 mm
• Patent inflow artery, free from significant lesion (>50%) as confirmed by angiography. Treatment of the target lesion is acceptable after successful treatment of inflow iliac and/or common femoral artery lesion. The inflow lesion cannot be treated with a DCB or a Drug Eluting Stent
• Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of the three vessels patent (<50% stenosis) to the ankle or foot with no planned intervention

Exclusion Criteria

• Previously stented target lesion
• Target lesion/ previously treated with drug-coated balloon <12 months prior to enrollment.
• Use of atherectomy, laser or other debulking devices in the target SFA/PPA vessel during the index procedure.
• Failure to cross the target lesion with the guide wire
• Presence of a complication following pre-dilation of target lesion, which in the opinion of the investigator would not allow the procedure to be performed in accordance with the REACT approach
• Presence of aneurysm in the target vessel.
• Prior on planned major amputation (above the ankle) in the target limb
• Acute ischemia and/or acute thrombosis of the target SFA/PPA vessel prior to enrollment.
• Perforation of the target vessel as evidenced by extravasation of contrast media prior to enrollment
• Known hypersensitivity or contraindication to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated
• Known hypersensitivity/allergy to Paclitaxel or other components of the investigational devices and comparator (e.g., nitinol, amorphous silicon carbide, polymer)
• Known hypersensitivity or contraindication to antiplatelet, anticoagulant, thrombolytic medications that would be administered during the study
• Subject with uncorrected bleeding disorders
• Subject with renal failure
• Life expectancy less than 12 months due to other comorbidities, that in the investigators opinion, could limit subject ability to comply with the study required follow-up visits/procedure and threaten the study scientific integrity
• Pregnant, breast feeding, or plan to become pregnant in the next 12 months.
• Current participation in another investigational drug or device clinical study that has not completed the primary endpoint at the time of enrollment or that upon investigator judgment could clinically interferes with the current study endpoints

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Koen Deloose, MD

Role: PRINCIPAL_INVESTIGATOR

Sint Blasius Hospital Dendermonde, Belgium

Patrice Bibombe Mwipatayi, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Perth Hospital

Michael Lichtenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Clinic Arnsberg

Locations

Royal Perth Hospital

Perth, Western Australia, Australia

Medical University Graz

Graz, , Austria

Medizinische Universität Wien

Vienna, , Austria

OLV Ziekenhuis

Aalst, , Belgium

A.Z. Sint-Blasius

Dendermonde, , Belgium

AZ Groeninge

Kortrijk, , Belgium

CHU de Nantes

Nantes, , France

Hopital Paris Saint Joseph

Paris, , France

Karolinen-Hospital, Klinikum Arnsberg

Arnsberg, , Germany

Universitäts-Herzzentrum Freiburg • Bad Krozingen

Bad Krozingen, , Germany

SRH Klinikum Karlsbad-Langensteinbach

Biederbach Baden-Wurttemberg, , Germany

Universitätsklinikum Leipzig

Leipzig, , Germany

Universitätsklinikum

Tübingen, , Germany

GRN Hospital

Weinheim, , Germany

Hospital General de Guadalajara

Guadalajara, , Spain

Countries

Australia; Austria; Belgium; France; Germany; Spain

Other Identifiers

C1706

Identifier Type: -

Identifier Source: org_study_id