An observational study in Peripheral Arterial Disease, sponsored by Spectranetics Corporation. Completed at 46 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Spectranetics Corporation (part of Philips) · Observational
Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's enrollment of 1,900 is above the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Spectranetics Corporation is the lead sponsor of 19 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
First submitted before Spectranetics Corporation became part of Philips.
Counted across the registry records on this site, refreshed daily.
Patients with symptomatic stenosis of the superficial femoral artery and/or popliteal artery intended to be treated with a Percutaneous Transluminal Angioplasty using the Stellarex OTW Drug -Coated Balloon
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with any medical condition that would make him/her inappropriate for treatment with Stellarex as per Instructions for Use (IFU) or investigator's opinion
Patients with severe disease of foot circulation defined as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RCC 2-3
Device: Percutaneous Transluminal Angioplasty
RCC 4-6 (CLI)
Device: Percutaneous Transluminal Angioplasty
Also known as: Stellarex™ OTW Drug-coated Angioplasty Balloon
Primary Efficacy Endpoint Cohort 1 - RCC 2-3:
Freedom from clinically-driven Target Lesion Revascularization (CD-TLR) at 12 months post- procedure.
Time frame: 12 months post-procedure
Primary Safety Endpoint-Cohort 1 - RCC 2-3
Freedom from device and procedure- related death through 30 days post-procedure and freedom from target limb major amputation and CD-TLR through 12 months post-procedure.
Time frame: 30 days post-procedure - 12Month post procedure
Primary effectiveness endpoint: Cohort 2 - RCC 4-6 (CLI)
Freedom from CD-TLR at 6 months post-procedure.
Time frame: 6 Months post procedure
Primary safety endpoint-Cohort 2 - RCC 4-6 (CLI)
Freedom from Composite MALE and POD through 30 days
Time frame: 30days
Rate and Freedom from events as specified in the description :Cohort 1 - RCC 2-3
* All-cause mortality at 12, 24 and 36 months post- procedure * Cardiovascular death at 12, 24, 36 months post- procedure * Procedural complication defined as occurrence of death, stroke, myocardial infraction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure * Device or procedure related death at 30 days * Major target limb amputation at 12, 24, 36 months post-procedure * CD-TLR through 12 (rate only), 24 and 36 months * Clinically Driven- Target Vessel Revascularization (CD- TVR) through 12, 24 and 36 months
Time frame: as specified in the description
Rate and Freedom-from-Cohort 2 - RCC 4-6
All-cause mortality at 6, 12, 24 and 36 months post- procedure * Cardiovascular death at 6, 12, 24, 36 months post- procedure * Procedural complication defined as occurrence of death, stroke, myocardial infraction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure * Device or procedure related death at 30 days o Major target limb amputation at 6, 12, 24, 36 months post-procedure * CD-TLR through 6 (rate only), 12, 24 and 36 months o Clinically Driven- Target Vessel Revascularization (CD- TVR) through 6, 12, 24 and 36 months * Wound healing rate through 6, 12, 24, and 36 months post-procedure * Minor amputation through 6, 12, 24 and 36 months * Amputation-free survival through 6, 12, 24 and 36 months
Time frame: As specified in the description
Plan to share: No
The record gives a start of Jun 2016, a primary completion of Oct 2021 and a completion of Dec 2021. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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