Obstructive DiseaseNCT04597307

IN.PACT™ Quality of Life Post-Reimbursement Study

An observational study of Obstructive Disease and Atherosclerosis of Femoral Artery, run by Medtronic at 9 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To prospectively collect and assess the perception of health-related Quality of Life, Pain and Walking Ability. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obstructive Disease, Atherosclerosis of Femoral Artery, Atherosclerosis of Popliteal Artery
What is being tested?: IN.PACT™ Admiral™ Drug Coated Balloon (DCB)
How many people: 80 participants
Where: 9 sitesFrance
Study dates: 17 Feb 2021to Dec 2024
How long will I take part?: 24 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study population includes patients with obstructive disease of the peripheral arteries that will have a percutaneous transluminal angioplasty (PTA) with the IN.PACT™ Admiral™ Drug Coated Balloon (DCB).

Who may be able to join

Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Patient has or is intended to receive or be treated with an eligible product
Patient is consented within the enrollment window of the treatment/therapy received

Who cannot join

Patient who is, or is expected to be inaccessible for follow-up
Patient with exclusion criteria required by local law
Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness)
Note: For this study, de novo patients will be enrolled to assess EQ-5D and WIQ at baseline and follow-up. Patients cannot be treated in the same procedure with a competitor drug-coated (DCB) or drug-eluting (DES) in the vessel segment treated with IN.PACT Admiral.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

France9 sites

Hopitaux Universitaires Paris lle-France Ouest- Hopital Ambroise- Pare
Boulogne
CHRU Brest Cavale Blanche
Brest
Centre Hospitalier Clermont-Ferrand-Gabriel-Montpied
Clermont-Ferrand, 63000
Groupe hospitalier Paris Saint-Joseph
Paris, 75674
Hopital Europeen Georges-Pompidou
Paris
CHU de Rennes
Rennes
Clinique Rhena
Strasbourg
Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil
Strasbourg
Clinique Pasteur
Toulouse

Other trials in France

About this study

To prospectively collect and assess the perception of health-related Quality of Life, Pain and Walking Ability.

Read the detailed description

To provide both the French National Authority for Health and the French Economic Committee for Health Products requested information on patient-reported outcomes for the IN.PACT™ Admiral™ Drug-Coated Balloon. Patients will be followed using routine clinical practice and the collection of two validated instruments: EuroQOL EQ-5D Quality of Life questionnaire and the Walking Impairment Questionnaire (WIQ).

Conditions: Obstructive Disease, Atherosclerosis of Femoral Artery, Atherosclerosis of Popliteal Artery
Being tested: IN.PACT™ Admiral™ Drug Coated Balloon (DCB)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IN.PACT™ Admiral™ Drug Coated Balloon (DCB)Combination product
For percutaneous transluminal angioplasty (PTA) in subjects with obstructive disease of the peripheral arteries.

Study groups in NCT04597307
Study group	Role	What they receive
IN.PACT™ Admiral™ DCB Cohort		De novo patients not previously treated with a DCB who are successfully treated with the IN.PACT™ Admiral™ DCB (ability to cross the target lesion). Receives: Combination Product: IN.PACT™ Admiral™ Drug Coated Balloon (DCB)

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of Life EQ-5D-5L French Index Score Change
Primary Objective: Assess the mean change of patient reported outcomes between pre-procedure visit (baseline) and 12 months after the endovascular procedure of the EQ-5D-5L Questionnaire using the French Index Score (from -0.530 to 1.000 with 1 being better) in the treatment of de novo PTA subjects with obstructive disease of peripheral arteries with the IN.PACT™ Admiral™ DCB.
Measured: Baseline & 12 months after endovascular procedure
Walking Ability Change
Primary Objective: Assess the mean change of patient reported outcomes between pre-procedure visit (baseline) and 12 months after the endovascular procedure of the Walking Impairment Questionnaire (WIQ) (0 to 100% with 100% being better) in the treatment of de novo PTA subjects with obstructive disease of peripheral arteries with the IN.PACT™ Admiral™ DCB.
Measured: Baseline & 12 months after endovascular procedure

Secondary outcomes (2)

Quality of Life EQ-5D-5L French Index Score Change Over Time
Assess the mean change of patient reported outcomes over time of EQ-5D-5L French Index Score (from -0.530 to 1.000 with 1 being better) collected at pre-procedure visit (baseline) and at 30 days, 12 months, and 24 months from the endovascular procedure in de novo patients treated with the IN.PACT™ Admiral™ DCB.
In addition, the EQ-5D VAS Score (0 to 100 with 100 being better) will be assessed using the mean change between pre-procedure visit (baseline) and 12 months after endovascular procedure as well as the mean change over time collected at preprocedure visit (baseline) and at 30 days, 12 months, and 24 months from the endovascular procedure with the IN.PACT™ Admiral™ DCB.
Measured: Baseline, 30 days, 12 months and 24 months from the endovascular procedure
Walking Ability Change Over Time
Assess the mean change of patient reported outcomes over time of the WIQ composite score (0 to 100% with 100% being better) collected at pre-procedure visit (baseline) and at 30 days, 12 months, and 24 months from the endovascular procedure in de novo patients treated with the IN.PACT™ Admiral™ DCB.
In addition, the WIQ questions for Walking Impairment, Walking Distance, Walking Speed, and Stair Climbing will be assessed using the mean change between pre-procedure visit (baseline) and 12 months after endovascular procedure as well as the mean change over time collected at preprocedure visit (baseline) and at 30 days, 12 months, and 24 months from the endovascular procedure with the IN.PACT™ Admiral™ DCB.
Measured: Baseline, 30 days, 12 months and 24 months from the endovascular procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 2021Dec 2024

First posted22 Oct 2020
Study start17 Feb 2021
Primary completion8 Nov 2023
Study completionDec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obstructive DiseaseStudies of the same condition, open and under way.
More trials run by MedtronicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 80 participants (actual)
Target duration: 24 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04597307
Sponsor's protocol ID: IN.PACT™ QoL PSR
Status last verified: Mar 2024
First submitted: 16 Sep 2020
Last updated: 15 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IN.PACT™ Quality of Life Post-Reimbursement Study
ClinicalTrials.gov ID: NCT04597307
Acronym / sponsor ID: IN.PACT™ QoL PSR
Conditions: Obstructive Disease, Atherosclerosis of Femoral Artery, Atherosclerosis of Popliteal Artery
Study type: Observational
Recruitment status: Unknown status
Enrolment: 80 participants (actual)
Lead sponsor: MedtronicIndustry (pharma, biotech, devices)
Study start: 17 Feb 2021 (actual)
Primary completion: 8 Nov 2023 (actual)
Study completion: Dec 2024 (estimated)
First posted: 22 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To prospectively collect and assess the perception of health-related Quality of Life, Pain and Walking Ability.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 24 Months
Number of arms: 1

Arm	Type	Receives
IN.PACT™ Admiral™ DCB Cohort	–	Combination Product: IN.PACT™ Admiral™ Drug Coated Balloon (DCB)De novo patients not previously treated with a DCB who are successfully treated with the IN.PACT™ Admiral™ DCB (ability to cross the target lesion).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population includes patients with obstructive disease of the peripheral arteries that will have a percutaneous transluminal angioplasty (PTA) with the IN.PACT™ Admiral™ Drug Coated Balloon (DCB).

Key inclusion criteria (3 listed)

Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Patient has or is intended to receive or be treated with an eligible product
Patient is consented within the enrollment window of the treatment/therapy received

Key exclusion criteria (4 listed)

Patient who is, or is expected to be inaccessible for follow-up
Patient with exclusion criteria required by local law
Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness)
Note: For this study, de novo patients will be enrolled to assess EQ-5D and WIQ at baseline and follow-up. Patients cannot be treated in the same procedure with a competitor drug-coated (DCB) or drug-eluting (DES) in the vessel segment treated with IN.PACT Admiral.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IN.PACT™ Admiral™ Drug Coated Balloon (DCB)For percutaneous transluminal angioplasty (PTA) in subjects with obstructive disease of the peripheral arteries.	Combination product	IN.PACT™ Admiral™ DCB Cohort

Primary outcome

Quality of Life EQ-5D-5L French Index Score Change
Time frame: Baseline & 12 months after endovascular procedure
Primary Objective: Assess the mean change of patient reported outcomes between pre-procedure visit (baseline) and 12 months after the endovascular procedure of the EQ-5D-5L Questionnaire using the French Index Score (from -0.530 to 1.000 with 1 being better) in the treatment of de novo PTA subjects with obstructive disease of peripheral arteries with the IN.PACT™ Admiral™ DCB.
Walking Ability Change
Time frame: Baseline & 12 months after endovascular procedure
Primary Objective: Assess the mean change of patient reported outcomes between pre-procedure visit (baseline) and 12 months after the endovascular procedure of the Walking Impairment Questionnaire (WIQ) (0 to 100% with 100% being better) in the treatment of de novo PTA subjects with obstructive disease of peripheral arteries with the IN.PACT™ Admiral™ DCB.

2 secondary outcomes

Quality of Life EQ-5D-5L French Index Score Change Over Time
Time frame: Baseline, 30 days, 12 months and 24 months from the endovascular procedure
Walking Ability Change Over Time
Time frame: Baseline, 30 days, 12 months and 24 months from the endovascular procedure

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Individual participant dataSharing planned: No

Related trials for Obstructive Disease

RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prof. Yann Goueffic, MD, PhD principal investigator

Hôpital Paris St Joseph

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Disease and Atherosclerosis of Femoral Artery, run by Medtronic at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life EQ-5D-5L French Index Score Change (time frame: Baseline & 12 months after endovascular procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04597307.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.