BIO REsponse Adapted Combination Therapy Pilot Study

NCT03547986 | Unknown

• 1 other identifier: C1706
• Study Type: interventional
• Target: 150
• Locations: 5 countries
• Sites: 14

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

Conditions

Peripheral Arterial Disease

Keywords

flow-limiting dissection; residual stenosis

Outcome Measures

Primary Outcomes (1)

• diagnostic accuracy of duplex ultrasound

  specificity and sensitivity of duplex ultrasound combined to angiography vs angiography alone

  during index procedure

Secondary Outcomes (22)

• diagnostic accuracy of intraarterial pressure measurement

  during index procedure

• diagnostic accuracy of intraarterial pressure measurement with IVUS

  during index procedure

• Target lesion stenting rate

  during index procedure

• Number of stents used per target lesion

  during index procedure

• Average stent length per target lesion

  during index procedure

Study Arms (2)

Duplex Ultrasound (DUS)

EXPERIMENTAL

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

Diagnostic Test: Duplex Ultrasound (DUS)

IVUS with Intraarterial pressure measurement (IAP)

EXPERIMENTAL

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

Diagnostic Test: IVUS with Intraarterial pressure measurement (IAP) if needed

Interventions

Duplex Ultrasound (DUS) DIAGNOSTIC_TEST

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

Also known as: Procedural diagnostic with Duplex Ultrasound (DUS)

Duplex Ultrasound (DUS)

IVUS with Intraarterial pressure measurement (IAP) if needed 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

Also known as: Procedural diagnostic with IVUS and Intraarterial pressure measurement (IAP)

IVUS with Intraarterial pressure measurement (IAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (15)

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Medical University Graz

Graz, Austria

Location

Medizinische Universität Wien

Vienna, Austria

Location

OLV Ziekenhuis

Aalst, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

CHU de Nantes

Nantes, France

Location

Hopital Paris Saint Joseph

Paris, France

Location

Karolinen-Hospital, Klinikum Arnsberg

Arnsberg, Germany

Location

Universitäts-Herzzentrum Freiburg • Bad Krozingen

Bad Krozingen, 79189, Germany

Location

SRH Klinikum Karlsbad-Langensteinbach

Biederbach Baden-Wurttemberg, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Universitätsklinikum

Tübingen, Germany

Location

GRN Hospital

Weinheim, Germany

Location

Hospital General de Guadalajara

Guadalajara, Spain

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Ultrasonography, Doppler, Duplex

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography, Doppler; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Koen Deloose, MD

  Sint Blasius Hospital Dendermonde, Belgium

  PRINCIPAL INVESTIGATOR

• Patrice Bibombe Mwipatayi, MD

  Royal Perth Hospital

  PRINCIPAL INVESTIGATOR

• Michael Lichtenberg, MD

  Clinic Arnsberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The existing and new diagnostic method are performed on the same patients (paired data)

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 6, 2018
• Study Start: November 9, 2018
• Primary Completion: January 3, 2022
• Study Completion: March 1, 2024
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); BE (3); ES (1); AU (2); DE (6)