Peripheral Artery DiseaseREACH PVINCT03943160

Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI

An observational study of Peripheral Artery Disease, run by Abbott Medical Devices at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Artery Disease
What is being tested?: Diamondback 360 Extended Length Orbital Atherectomy System
Type of treatment: Medical device
How many people: 50 participants
Where: 6 sitesUnited States
Study dates: 11 Jun 2019to 11 Dec 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.

Who may be able to join

Subject is ≥ 18 years
Subject is willing and able to sign the IRB-approved informed consent form (ICF)
Subject presents with a Rutherford Classification of 2 to 5
Subject has a positive Allen's Test
Subject to undergo peripheral angiography and/or PVI via TRA approach per physician discretion
Index Procedure Inclusion Criteria:

Show all 9Show fewer

Physician obtains successful radial artery access (Note: snuffbox access is allowed)
Target lesion appropriate (i.e. location/morphology) for OA treatment via TRA within target area
OAS use attempted (defined as ViperWire introduced into the body)

Who cannot join

Subject has no palpable radial artery on the planned access arm
Subject has a previous failed radial access attempt on planned access arm
Subject has a dialysis fistula on planned access arm
Subject has a known subclavian stenosis or occlusion
Subject has a previous subclavian stent or previous subclavian intervention
Subject has a shunt in the radial artery on the planned access arm

Show all 17Show fewer

Subject has evidence of osteomyelitis
Subject is currently participating in an investigational drug or device study
Subject is pregnant within the study period
Index Procedure Exclusion Criteria
Physician unable to obtain radial artery access
Physician determines TRA is not acceptable due to patient anatomy, lesion characteristics, and/or disease severity
OAS use not attempted (defined as ViperWire introduced into the body)
Prior to insertion of ViperWire:
Femoral access is obtained
Unsuccessful peripheral intervention
A reportable adverse event has occurred

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Mercy Hospital, Springfield
Chesterfield, Missouri, 63017
Cardiovascular Institute of the South - Lafayette General South West OBL
Lafayette, Louisiana, 70506
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Columbia University Medical Center/New York Presbyterian
New York, New York, 10032
Sorin Medical, P.C.
New York, New York, 10065
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016

Other trials in United States

About this study

The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.

Read the detailed description

The purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions.

Conditions: Peripheral Artery Disease
Being tested: Diamondback 360 Extended Length Orbital Atherectomy System
Medical subject headings: Peripheral Arterial Disease

What participants receive

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

Diamondback 360 Extended Length Orbital Atherectomy SystemDevice
Also called Stealth 360 Extended Length Orbital Atherectomy System
All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.

What is being measured

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

Procedural Success:
Successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access (TRA) related events. Serious TRA related events consist of: Serious TRA site bleeding, serious TRA site hematoma, serious radial artery spasm, serious hand ischemia, stroke, Transient Ischemic Attach (TIA), Serious nerve damage, perforation, TRA site pseudoaneurysm.
Measured: Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure)

Secondary outcomes (1)

Treatment Success:
Treatment success is defined as <50% residual stenosis post-procedure and without significant angiographic complications without stent placement, or <30% residual stenosis post-procedure and without significant angiographic complications with stent placement.
Measured: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours

Timeline

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

11 Jun 201911 Dec 2019

First posted9 May 2019
Study start11 Jun 2019
Primary completion11 Dec 2019
Study completion11 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe 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: Other
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03943160
Sponsor's protocol ID: CLN-0012-P
Acronym: REACH PVI
Status last verified: Jul 2023
First submitted: 3 May 2019
Last updated: 18 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Lodha A, Giannopoulos S, Sumar R, Ratcliffe J, Gorenchtein M, Green P, Rollefson W, Stout CL, Armstrong EJ. Transradial Endovascular Intervention: Results From the Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention (REACH PVI) Study. Cardiovasc Revasc Med. 2022 Mar;36:115-120. doi: 10.1016/j.carrev.2021.05.011. Epub 2021 May 15.
PubMed 34020900

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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Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
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All Peripheral Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
ClinicalTrials.gov ID: NCT03943160
Acronym / sponsor ID: REACH PVI / CLN-0012-P
Conditions: Peripheral Artery Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 11 Jun 2019 (actual)
Primary completion: 11 Dec 2019 (actual)
Study completion: 11 Dec 2019 (actual)
First posted: 9 May 2019 (actual)
Results: Posted 3 Mar 2021

Clinical summary

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

The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.

Key inclusion criteria (9 listed)

Subject is ≥ 18 years
Subject is willing and able to sign the IRB-approved informed consent form (ICF)
Subject presents with a Rutherford Classification of 2 to 5
Subject has a positive Allen's Test
Subject to undergo peripheral angiography and/or PVI via TRA approach per physician discretion

Key exclusion criteria (17 listed)

Subject has no palpable radial artery on the planned access arm
Subject has a previous failed radial access attempt on planned access arm
Subject has a dialysis fistula on planned access arm
Subject has a known subclavian stenosis or occlusion
Subject has a previous subclavian stent or previous subclavian intervention

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
Diamondback 360 Extended Length Orbital Atherectomy SystemAlso: Stealth 360 Extended Length Orbital Atherectomy SystemAll patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.	Device	–

Primary outcome

Procedural Success:
Time frame: Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure)
Successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access (TRA) related events. Serious TRA related events consist of: Serious TRA site bleeding, serious TRA site hematoma, serious radial artery spasm, serious hand ischemia, stroke, Transient Ischemic Attach (TIA), Serious nerve damage, perforation, TRA site pseudoaneurysm.

1 secondary outcome

Treatment Success:
Time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours

Results and safety

Results posted to the registry on 3 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OAS Use Via Transradial Access (TRA)	50	50

Primary outcome: Procedural Success:

Time frame: Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure). Count of participants. Unit: Participants

Measure	OAS Use Via Transradial Access (TRA) n = 50
Value	49

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The reporting of adverse events (AEs) began immediately after the subject was enrolled through the first standard of care follow-up visit (7 - 45 days post-procedure). For the purposes of this study, pre-planned interventions noted at baseline were not considered reportable AEs.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OAS Use Via Transradial Access (TRA)	2 of 50 (4%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 34020900Lodha A, Giannopoulos S, Sumar R, Ratcliffe J, Gorenchtein M, Green P, Rollefson W, Stout CL, Armstrong EJ. Transradial Endovascular Intervention: Results From the Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention (REACH PVI) Study. Cardiovasc Revasc Med. 2022 Mar;36:115-120. doi: 10.1016/j.carrev.2021.05.011. Epub 2021 May 15.

Related trials for Peripheral Artery Disease

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Artery Disease, run by Abbott Medical Devices at 6 sites in United States.

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 9 inclusion and 17 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: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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?

Yes. Results are posted in the registry (first posted 3 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Procedural Success: (time frame: Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure)). 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 NCT03943160, which also lists 1 linked publication.

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 18 Jul 2023.