Paclitaxel Coated Balloon for Bowel Stricture

(PATENT-B Trial)

Recruiting at 33 trial locations

Overseen By Erika Wang

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GIE Medical

Must not be taking: Anticoagulants, Antiplatelets, Steroids, others

Disqualifiers: Pregnancy, Malignancy, Inflammation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

171 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the ProTractX3™ paclitaxel-coated balloon to determine its effectiveness for recurring benign bowel strictures. These non-cancerous narrowings in the intestines make it difficult for food to pass. The trial aims to assess whether this treatment is safe and more effective than usual care. Individuals with a problematic bowel stricture that has required at least two previous treatments and continues to recur may find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, providing access to a potentially effective treatment before it becomes widely available.

Will I have to stop taking my current medications?

The trial requires participants to stop using chronic systemic steroids (more than 10 mg/day) for at least 4 weeks before joining. If you are on anticoagulant or antiplatelet medications, they must be managed safely according to guidelines. Other medications are not specifically mentioned in the protocol.

What prior data suggests that the Paclitaxel Coated Balloon is safe for treating bowel strictures?

Research has shown that paclitaxel-coated balloons, like the one tested in this trial, have been safe in earlier studies. For instance, one study found that a similar balloon used for blocked blood vessels was safe over the long term, with 75% of patients not needing additional procedures for up to five years. This indicates that most patients tolerate the treatment well.

However, some precautions are necessary. The treatment is not recommended for individuals allergic to paclitaxel. Discuss any allergies or concerns with the research team before joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The Paclitaxel Coated Balloon is unique because it introduces a novel way of addressing bowel strictures by combining mechanical dilation with targeted drug delivery. Unlike standard treatments that often rely solely on surgical methods or plain balloon dilation, this device releases paclitaxel, a drug that helps prevent scar tissue from reforming. Researchers are excited because this method could potentially offer longer-lasting relief from strictures with less need for repeat procedures. Moreover, the use of a drug-coated balloon is a minimally invasive approach, which could enhance recovery times for patients compared to traditional surgical options.

What evidence suggests that the ProTractX3™ TTS DCB is effective for treating bowel strictures?

Research has shown that balloons coated with paclitaxel yield promising results for treating blood vessel blockages. In some studies, these balloons kept blood vessels open longer, with 75% of patients avoiding additional procedures for up to five years. This suggests that the paclitaxel coating helps maintain open vessels by slowing tissue regrowth. While these results primarily apply to blood vessel treatments, they suggest similar benefits might occur in bowel blockages. In this trial, participants will receive either the ProTractX3 Drug-coated balloon or standard care to evaluate its effectiveness in treating bowel blockages. Early results in similar conditions encourage the use of this technology for bowel blockages. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

Adults over 22 with benign bowel strictures that have been dilated twice before can join. They must be able to follow the study plan and give consent. Pregnant or breastfeeding women, those with paclitaxel allergies, or people on certain medications are excluded.

Inclusion Criteria

My stricture is 5 cm long or shorter.

Willing and able to provide written informed consent

I am 22 years old or older.

Exclusion Criteria

My condition cannot be treated with standard balloon dilation due to severe issues.

I might have a tear in my digestive tract.

My condition needs immediate medical attention.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the ProTractX3 Drug-coated balloon for recurrent benign bowel strictures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Paclitaxel Coated Balloon

Trial Overview The trial is testing GIE Medical's ProTractX3 TTS DCB against a control for treating non-cancerous bowel narrowings. It aims to see if this treatment is safe and works well in keeping the bowels open.

How Is the Trial Designed?

Group I: GIE Medical ProTractX3 TTS DCB Experimental Treatment 1 Intervention

The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.

Group II: Control Active Control 1 Intervention

Standard of Care.

Paclitaxel Coated Balloon is already approved in European Union, United States for the following indications:

Approved in European Union as Paclitaxel Coated Balloon for:

• Peripheral artery disease
• Above-the-knee PAD
• Below-the-knee PAD

Approved in United States as Paclitaxel Coated Balloon for:

• Peripheral artery disease
• Above-the-knee PAD
• Critical limb ischemia

Who Is Running the Clinical Trial?

GIE Medical

Lead Sponsor

Trials

5

Recruited

400+

Published Research Related to This Trial

Paclitaxel-conjugated micelles, especially the M(FA/PTX) formulation, demonstrated superior anti-tumor activity in breast cancer models, with a significant reduction in tumor mass and increased cell apoptosis compared to standard paclitaxel and control groups.

The M(FA/PTX) micelles not only enhanced the effectiveness of paclitaxel but also improved survival rates in tumor-bearing mice, suggesting they could be a promising treatment option for human breast cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-tumor activity of folate targeted biodegradable polymer-paclitaxel conjugate micelles on EMT-6 breast cancer model. Wu, D., Zheng, Y., Hu, X., et al.[2018]

A rare case of acute coronary syndrome occurred due to anaphylaxis after using a paclitaxel-coated balloon for treating a blocked superficial femoral artery, highlighting a potential safety concern with this treatment.

Drug-coated balloons, while effective in reducing restenosis in peripheral arterial disease, may carry risks of severe allergic reactions, which clinicians should be aware of when using these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kounis Syndrome after Angioplasty of the Superficial Femoral Artery with Paclitaxel-Coated Balloon. Narroway, HG., Katib, N., Gomes, ML., et al.[2020]

In a study involving 18 healthy swine, the In.Pact Pacific paclitaxel-coated balloon (PCB) showed higher tissue concentrations of the drug compared to other PCB technologies (Lutonix and Ranger) at all measured time points, indicating its potential for more effective treatment.

All PCB technologies effectively reduced neointimal growth compared to control balloons, but the In.Pact PCB demonstrated superior inhibition, while the lower-dose PCBs (2 μg/mm²) resulted in more mature neointima with fewer fibrin deposits, suggesting a favorable healing response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Paclitaxel Dose on Tissue Pharmacokinetics and Vascular Healing: A Comparative Drug-Coated Balloon Study in the Familial Hypercholesterolemic Swine Model of Superficial Femoral In-Stent Restenosis. Gongora, CA., Shibuya, M., Wessler, JD., et al.[2017]

In a study of 238 patients, those treated with paclitaxel-coated balloon angioplasty (PCBA) had a significantly lower 5-year mortality rate (14.0%) compared to those who received standard plain balloon angioplasty (POBA) (26.2%), indicating that PCBA may be a safer option.

However, when analyzing matched pairs of patients, there was no significant difference in mortality rates between the two groups (20.8% for PCBA vs. 26.0% for POBA), suggesting that PCBA does not increase long-term mortality compared to POBA, and the dose of paclitaxel used did not correlate with mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study. Donas, KP., Sohr, A., Pitoulias, GA., et al.[2020]

This case report is the first to show that nab-paclitaxel can successfully treat patients who have severe hypersensitivity reactions to paclitaxel and docetaxel.

Nab-paclitaxel is demonstrated to be a safe alternative chemotherapy option for patients who cannot tolerate traditional taxane treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment with nab-paclitaxel after hypersensitivity reaction to paclitaxel and docetaxel. de Leon, MC., Bolla, S., Greene, B., et al.[2021]

The Stellarex® drug-coated balloon (DCB) effectively delivers a low dose of paclitaxel to treat vascular lesions, utilizing a unique hybrid formulation that ensures drug integrity and release during use.

Clinical data indicate that Stellarex maintains long-term effectiveness in treating patients without any significant safety concerns, suggesting it is a reliable option for vascular interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellarex drug-coated balloon: a technology evaluation. Nerla, R., Castriota, F., Cremonesi, A., et al.[2021]

In the IN.PACT SFA Trial involving 331 patients, the paclitaxel-coated drug-coated balloon (DCB) demonstrated significantly higher primary patency rates (82.2%) compared to percutaneous transluminal angioplasty (PTA) (52.4%) at 12 months, indicating better long-term effectiveness in treating superficial femoral and popliteal artery disease.

The DCB also had a much lower rate of clinically driven target lesion revascularization (2.4% vs. 20.6% for PTA), while both treatments showed low rates of vessel thrombosis and no major complications, highlighting the DCB's favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Tepe, G., Laird, J., Schneider, P., et al.[2022]

Paclitaxel oleate, a lipophilic prodrug of paclitaxel, was successfully formulated into nanoparticles using a hydrophobic polymer, which allows for better drug delivery in the acidic environment of tumors, potentially replacing the toxic Cremophor EL used in traditional formulations.

The study demonstrated that paclitaxel oleate in PbAE nanoparticles showed similar cytotoxicity to free paclitaxel, with IC50 values of 123 nM and 128 nM respectively, while the prodrug in a different formulation (PCL) was significantly less effective, indicating that the new formulation enhances drug efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation and characterization of polymeric pH-sensitive STEALTH® nanoparticles for tumor delivery of a lipophilic prodrug of paclitaxel. Lundberg, BB.[2015]

The Optilume™ paclitaxel-coated balloon treatment for recurrent bulbar urethral strictures showed no serious adverse events within 90 days, indicating a strong safety profile for this intervention.

At the 12-month follow-up, 70% of patients achieved anatomic success, suggesting promising preliminary efficacy for this treatment, warranting further long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study. Virasoro, R., DeLong, JM., Mann, RA., et al.[2020]

The Pantera Lux paclitaxel-coated balloon demonstrated high clinical device success (98.2%) in treating 1,064 patients with in-stent restenosis and de novo lesions, confirming its efficacy in a real-world setting.

The study reported low rates of major adverse cardiac events (MACE) at 12 months, with an overall rate of 15.1%, indicating the safety of the intervention, along with a very low incidence of stent thrombosis at 0.4%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry. Toelg, R., Merkely, B., Erglis, A., et al.[2015]

A new method for quantifying paclitaxel (PTX) levels in plasma using HPLC with UV detection has been developed, which is reliable and efficient for clinical use, allowing for therapeutic drug monitoring.

The method demonstrated a strong linearity in measuring PTX concentrations and showed good precision, making it suitable for managing the drug's narrow therapeutic range and variability in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation method for estimation paclitaxel in plasma. Gaïes, E., Jebabli, N., Ben Said, D., et al.[2021]

The controlled-release PACLIMER Microspheres containing 40% paclitaxel significantly reduced tumor growth in prostate cancer models, indicating its efficacy as a treatment.

When combined with radiation, the 10% PACLIMER Microspheres enhanced tumor response, suggesting that this formulation can act as a radiosensitizer, improving the effectiveness of radiation therapy in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-tumor effect of combination therapy with intratumoral controlled-release paclitaxel (PACLIMER microspheres) and radiation. Lapidus, RG., Dang, W., Rosen, DM., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05561127

Paclitaxel Coated Balloon for the Treatment of Chronic ... The items on the GIQLI-10 align closely with common obstructive symptoms found in patients with bowel strictures. 6 Months Post-Procedure. Other Outcome ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190019B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Ranger Paclitaxel-Coated PTA Balloon Catheter is indicated for percutaneous transluminal angioplasty (PTA) of de novo or restenotic lesions ...

3. medtronic.com medtronic.com/me-en/healthcare-professionals/products/cardiovascular/drug-coated-balloons/inpact-drug-coated-balloon/clinical-outcomes.html

Clinical Outcomes - IN.PACT Admiral The outcomes from the IN.PACT SFA Trial demonstrate long-term safety and effectiveness, with 75% of patients reintervention-free through five years.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11995917/

Safety and Efficacy of a Paclitaxel-Coated Balloon for the ... In summary, the Stellarex® DCB has demonstrated promising clinical outcomes in treating long SFA lesions, with sustained patency rates and ...

5. vanderbilt.trialstoday.org vanderbilt.trialstoday.org/trial/NCT05561127

Paclitaxel Coated Balloon for the Treatment of Chronic ... Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel. Print. Purpose. To determine the safety and efficacy of GIE ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140010c.pdf

IN.PACT™ Admiral™ - Paclitaxel-coated PTA Balloon Catheter The outcomes are shown in Primary Safety Composite and Primary Effectiveness by. Gender (Table 10). The results of an interaction analysis indicate that the ...